Depuy Orthopaedics, Inc.
FDA adverse event reports naming Depuy Orthopaedics, Inc. as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: DEPUY ORTHOPAEDICS, INC..
- Total reports
- 53,665
- Deaths
- 32
- Injuries
- 41,567
- Malfunctions
- 11,936
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.
Top device categories
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedLPH8,890
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/PolymerJWH7,077
- Orthopedic Manual Surgical InstrumentLXH6,682
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, CementedJDI4,860
- Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)KWA3,581
- Prosthesis, Hip, Hemi-, Acetabular, Cemented, MetalKWB2,886
- Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or UncementedKWY2,605
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile BearingNJL2,052
- Prosthesis, Knee, Hemi-, Tibial, Resurfacing (Uncemented)HSH1,869
- Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/PolymerHRY1,610
Recent recalls
- 2024-03-29Open, ClassifiedProcess change control
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product incorrectly labelled.
- 2023-03-17Open, ClassifiedLabeling Change Control
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-17Open, ClassifiedLabeling Change Control
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-17Open, ClassifiedLabeling Change Control
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-17Open, ClassifiedLabeling Change Control
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2023-03-17Open, ClassifiedLabeling Change Control
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- 2020-02-13TerminatedProcess control
SPECIALIST 2 DISTAL FEMORAL CUTTING BLOCK. Part code 966115. The product is a femoral cutting block.
The device will not connect to the Specialist 2 Locating Outrigger which renders them unusable in surgery.
- 2018-04-30TerminatedProcess control
ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
There may be burrs on the extraction hole threads.
- 2018-04-30TerminatedProcess control
ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee
There may be burrs on the extraction hole threads.
- 2018-03-20TerminatedUnder Investigation by firm
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645; (5) Sigma HP Cemented Trochlea Size 5 Narrow Left, Catalog Number: 102403500, GTIN: 10603295001652; (6) Sigma HP Cemented Trochlea Size 1 Narrow Right, Catalog Number: 102404100, GTIN: 10603295001669; (7) Sigma HP Cemented Trochlea Size 2 Narrow Right, Catalog Number: 102404200, GTIN: 10603295001676; (8) Sigma HP Cemented Trochlea Size 3 Narrow Right, Catalog Number: 102404300, GTIN: 10603295001683; (9) Sigma HP Cemented Trochlea Size 4 Narrow Right, Catalog Number: 102404400, GTIN: 10603295001690; (10) Sigma HP Cemented Trochlea Size 5 Narrow Right, Catalog Number: 102404500, GTIN: 10603295001706
The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process.
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