Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented
FDA adverse event reports and recall history for prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented (product code PAO), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 746
- Deaths
- 1
- Injuries
- 670
- Malfunctions
- 74
Reports per year
Source: FDA adverse event reports by year received, 2014–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-09-27Open, ClassifiedUnder Investigation by firm
Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
- 2017-02-11TerminatedDevice Design
Comprehensive Reverse Shoulder System Humeral Tray Model 115340
Higher than anticipated rate of fracturing due to design. Risk of revision surgery due to fracturing.
- 2013-06-17TerminatedDevice Design
Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
Monitor prosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented automatically
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