Arthrex® AR-501-UFLDRecalls & reported problems
Arthrex, Inc. · IBAL UKA FEM CEMENTED SIZ 4,L-MEDIAL · Class 2 · Implant
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867034273), received between Dec 16, 2019 and Aug 29, 2022 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Naturally Worn” (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
- Naturally Worn1
- Output Problem1
- Unstable1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2022Output Problem
ON 08/08/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT DURING A MEDIAL UNI-COMPARTMENTAL KNEE REPLACEMENT A AR-501-UFLD IBALANCE¿ UKA FEMORAL,CEMENTED SIZE 4S THE CEMENT BECAME TO FIRM WHEN TRYING TO IMPLANT THE FEMORAL COMPONENT. NOT BEING ABLE TO FULLY SEAT THE FEMORAL COMPONENT, THE COMPONENT WAS THEN REMOVED AS WELL AS THE CEMENT REMOVED AND A NEW BATCH OF CEMENT MIXED. A 2ND COMPONENT WAS OPENED, AS ALL THE PRIOR CEMENT COULD NOT BE REMOVED FROM THE ORIGINAL IMPLANT. IT WAS ALSO FOUND THAT THE TIBIAL ACL INSERTION HAD AVULSED, THAT WAS REPAIRED BACK DOWN TO THE TIBIA WITH A 4.5 CANNULATED SCREW AND WASHER, AS WELL AS A FIBERTAPE FIXATED WITH A SWIVELOCK INTO THE PROXIMAL TIBIA. THE CASE WAS COMPLETED, WITH NO PATIENT EFFECT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15310539 ↗InjuryDec 16, 2019Unstable; Naturally Worn
THE PATIENT HAD ORIGINAL SURGERY FOR A UNI KNEE REPLACEMENT ON (B)(6) 2018. SHE REPORTED PAIN AND INSTABILITY; XRAYS SHOWED THAT THE POLY HAD WORN DOWN. ARTHREX PARTS AR-521-TBA8, AR-501-UFLD AND AR-501-TTLA WERE REMOVED. A TOTAL KNEE REVISION WAS DONE ON (B)(6) 2019 WITH A COMPETITOR'S DEVICE. PATIENT FEMALE, 60S.
Patient problems: Pain
MAUDE report 9473632 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
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- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- 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 13, 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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