Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
FDA adverse event reports and recall history for prosthesis, shoulder, hemi-, humeral, metallic uncemented (product code HSD), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 10,126
- Deaths
- 34
- Injuries
- 8,253
- Malfunctions
- 1,561
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
- 2015-09-02TerminatedNonconforming Material/Component
SMR Shoulder/Spalla Trial Heads ECC .4 mm Adaptor, REF 9013.30.021; SMR Shoulder/Spalla Trial Heads ECC .8 mm Adaptor, REF 9013.30.031; for use in shoulder implant surgery.
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
- 2015-02-12TerminatedNo Marketing Application
Arthrosurface 25&30mm 10.5x28mm Taper Post Fixation Component; Catalog Number: 6105-0028, Pat Number 1105-0028. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- 2015-02-12TerminatedNo Marketing Application
Arthrosurface 25&30mm 12.5x32mm Taper Post Fixation Component; Catalog Number: 6125-0035, Part Number: 1125-0035. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- 2015-02-12TerminatedNo Marketing Application
Arthrosurface 35mm 13.5x32mm Taper Post Fixation Component; Catalog Number: 8135-0032, Part Number: 3135-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- 2015-02-12TerminatedNo Marketing Application
Athrosurface 40mm 13.75x31mm Taper Post Fixation Component; Catalog Number: 8135-1875 Part Number: 3135-1875. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- 2015-02-12TerminatedNo Marketing Application
Arthrosurface HHXL (OVO) 15.6x32mm Taper Post Fixation Component; Catalog Number: 8156-0032, Part Number: 156-0032. HemiCAP Contoured Articular Prosthetic for Humeral head resurfacing. Orthopedic shoulder prosthesis component.
Fully threaded Taper Post Fixation components not cleared for marketing in the US with current indications.
- 2013-07-10TerminatedPackaging process control
Bigliani/Flatow The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
The firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
- 2013-04-17TerminatedPackaging change control
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Biomet part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
- 2009-11-12TerminatedOther
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, Zimmer, Warsaw, IN, REF 4342-112-13. Shoulder replacement surgery.
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
- 2009-11-12TerminatedOther
Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, Zimmer, Warsaw, IN, REF 4348-112-13. Shoulder replacement surgery.
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
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