Knee Arthroplasty Implantation System
FDA adverse event reports and recall history for knee arthroplasty implantation system (product code OOG), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 254
- Deaths
- 0
- Injuries
- 190
- Malfunctions
- 64
Reports per year
Source: FDA adverse event reports by year received, 2010–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2015-10-21TerminatedProcess design
ConForMIS iUni Unicondylar Knee Replacement System: iUNI G2, Left Lateral Catalog Number: M57220600230 (US) M5722INT0600230 (OUS)
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConForMIS Unicondylar Knee Replacement System iUNI G2, Left Medial Catalog Number: M57220600210(US) M5722INT0600210 (OUS)
May contain small amounts of ethylene glycol residue
- 2015-10-21TerminatedProcess design
ConForMIS iUNI Unicondylar Knee Replacement System iUNI G2, Right Lateral Catalog Number: M57220600240 (US) M5722INT0600240 (OUS)
May contain small amounts of ethylene glycol residue
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