Prosthesis, Hip, Femoral, Resurfacing

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2012-11-06TerminatedError in labeling

  Metasul Durom Femoral component Sterile, Rx

  Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

• 2011-03-24TerminatedDevice Design

  ASR FEMORAL IMPLANT SIZE 39, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  TOTAL ASR FEM IMP SIZE 41, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  TOTAL ASR FEM IMP SIZE 43, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  TOTAL ASR FEM IMP SIZE 45, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  ASR FEMORAL IMPLANT SIZE 47, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  ASR FEMORAL IMPLANT SIZE 49, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  ASR FEMORAL IMPLANT SIZE 51, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  ASR FEMORAL IMPLANT SIZE 53, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the

• 2011-03-24TerminatedDevice Design

  ASR FEMORAL IMPLANT SIZE 55, DEPUY ASR RESURFACING FEMORAL HEADS, DePuy Articular Surface Replacement (ASR) Hip Prosthesis System. The DePuy ASR Resurfacing Femoral Heads are designed for use in hemi-arthroplasty applications to replace the articular surface of the femoral head. The implants consist of a one-piece, cobalt-chromium-molybdenum (Co-Cr-Mo) metal femoral head with a short stem used as a cential guide pin. The implants range in sizes 39mm through 63mm to suit varying patient anatomy. The femoral resurfacing heads have a polished exterior surface and an internal cavity designed for use with bone cement for fixation to the patient's prepared femoral head. The implant allows for the minimal removal of bone from the femoral head, replacing the bone with a metal shell (cap). Articulation occurs between the polished femoral resurfacing implant and the patient's natural acetabulum. Prescription Use, Sterile. The DePuy ASR Resurfacing Femoral Heads are intended for cemented use in partial hip replacement procedures (hemi-arthroplasty). Indications are for patients suffering severe pain and disability due to osteoarthritis, rheumatoid arthritis, congenital hip dysplasia, post-traumatic arthritis, avascular necrosis, or slipped capital femoral epiphysis. Additional indications include other abnormalities where major pathology affects the femoral head; where the acetabular cavity is normal and not deformed or weakened; and where acetabular replacement is either not required or not desirable.

  As part of our ongoing post-market surveillance of all products, DePuy is continually evaluating data from a variety of sources including national joint replacement registries, published literature, company sponsored clinical trials, internal complaints data and unpublished clinical research reports. DePuy Orthopaedics issued a Field Safety Notice in March 2010 after receiving new data from the