Arthrex® AR-501-UFRDRecalls & reported problems
Arthrex, Inc. · IBAL UKA FEM CEMENTED SIZ 4,R-MEDIAL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867034334), received between Jun 26, 2018 and Jun 26, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Device Slipped1
Patient problems
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 26, 2018Device Slipped
IT WAS REPORTED BY THE PATIENT THAT HE UNDERWENT A UNI-KNEE PROCEDURE ON HIS RIGHT KNEE ON (B)(6) 2013. DURING THE PROCEDURE THE FOLLOWING ARTHREX PARTS WERE IMPLANTED: AR-501-TTRD, LOT 108761138; AR-501-TBD8, LOT 77941146; AR-501-UFRD, LOT 108761138. APPROXIMATELY 4-6 MONTHS AFTER THE PROCEDURE PATIENT BEGAN TO NOTICE SLIPPING IN HIS KNEE AND A STRONG STABBING PAIN THAT EVENTUALLY BECAME UNBEARABLE. PATIENT UNDERWENT A REVISION PROCEDURE (B)(6) 2015 FROM A UNI-KNEE TO A TOTAL-KNEE. DURING THE REVISION PROCEDURE ALL ARTHREX IMPLANTS WERE EXPLANTED AND ANOTHER MANUFACTURER'S PRODUCT WAS USED TO COMPLETE THE REVISION. THE PATIENT HAD OBTAINED THE EXPLANTED DEVICES FROM THE FACILITY. PATIENT HAS AGREED TO SEND THE PRODUCTS TO ARTHREX FOR EVALUATION AND HAS REQUESTED TO RECEIVE A COPY OF THE EVALUATION RESULTS.
Patient problems: Pain
MAUDE report 7638384 ↗
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- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
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- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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