Arthrex® AR-501-UFRCRecalls & reported problems
Arthrex, Inc. · IBAL UKA FEM CEMENTED SIZ 3,R-MEDIAL · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867034327), received between Aug 15, 2022 and Aug 15, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.
Most reported problems
Device problems
- Loosening of Implant Not Related to Bone-Ingrowth1
Patient problems
- Failure of Implant1
- Loss of Range of Motion1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 15, 2022Loosening of Implant Not Related to Bone-Ingrowth
ON 7/25/2022, IT WAS REPORTED THROUGH A PATIENT'S LEGAL FILING THAT ON (B)(6) 2018 THE PATIENT UNDERWENT A RIGHT KNEE MEDIAL UNI-COMPARTMENTAL KNEE ARTHROPLASTY USING THE FOLLOWING ARTHREX IBALANCE UNI-COMPARTMENTAL KNEE SYSTEM DEVICES: IBALANCE UKA TIBIAL BEARING IMPLANT, SIZE 4 AR-521-TBD8 (LOT 5791631), IBALANCE UKA FEMORAL SIZE 3 AR-501-UFRC (LOT 10144742) AND IBALANCE UKA TIBIAL TRAY SIZE 4 AR-501-TTRD (LOT 10223657) THEREAFTER ON (B)(6) 2019 THE PATIENT COMPLAINED OF ACHES AND PAINS IN THE KNEE AND DURING THE VISIT THE SURGEON DISCUSSED A POTENTIAL REVISION. THE PATIENT AGAIN REPORTED ACHES AND PAINS ON (B)(6) 2020. ON (B)(6) 2020 THE PATIENT PRESENTED TO A DIFFERENT SURGEON WITH COMPLAINTS OF PAIN AND TENDERNESS AND AN ASPIRATION OF THE RIGHT KNEE WAS PERFORMED AND REVEALED LIMITED RANGE OF MOTION. THE SURGEON THEN RECOMMENDED A REVISION PROCEDURE DUE TO LOOSENING. ON (B)(6) 2021 THE SURGEON PERFORMED A RIGHT REVISION TOTAL KNEE ARTHROPLASTY, BOTH COMPONENTS. IT IS UNKNOWN WHAT MANUFACTURERS DEVICES WERE UTILIZED TO COMPLETE THE REVISION PROCEDURE. NO FURTHER DETAILS HAVE BEEN GIVEN.
Patient problems: Failure of Implant; Loss of Range of Motion; Pain
MAUDE report 15226418 ↗
Other PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- 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
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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