Arthrex® AR-501-TTRDRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888867034211), received between Jun 26, 2018 and Aug 15, 2022 — classified as 1 injury, 1 malfunction.

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

Recent adverse event reports

The 2 most recent of 2 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 15226466 ↗
• 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 7638440 ↗