Arthrex® AR-513-BD10Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107151), received between Apr 4, 2017 and Apr 4, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 4, 2017Patient-Device Incompatibility

  IT WAS REPORTED THAT ON (B)(6) 2015 PATIENT UNDERWENT A RIGHT TKA PROCEDURE. PATIENT HAD A REVISION PROCEDURE ON (B)(6) 2016 DURING WHICH THE TIBIAL BEARING WAS EXCHANGED (1220246-2016-00144 / CC84443). ON (B)(4) 2017 THE SURGEON PERFORMED A REVISION RIGHT TKA DUE TO PATIENT PAIN. IT WAS REPORTED THAT THE TIBIA WAS NOT LOOSE. DURING THE (B)(6) 2017 REVISION PROCEDURE THE SURGEON EXPLANTED THE TIBIAL TRAY AR-503-TTTD (LOT 1297049) (CC108785 LINE 186615), FEMORAL IMPLANT AR-516-4R (LOT 1368092) (CC108785 LINE 186616), PATELLA IMPLANT AR-504-PSC9 (LOT 113601437) (CC108785 LINE 186617) AND BEARING IMPLANT AR-513-BD14 (LOT 113601329) (CC108785 LINE 187428). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT IS A FEMALE, DOB (B)(6). THE FOLLOWING WAS OBTAINED FROM THE PATIENT'S MEDICAL RECORDS: RECORDS DATE 5/20/2016: PATIENT HAD BEEN DOING WELL UNTIL TRIPPING AND FALLING ONTO A FLEXED KNEE APPROXIMATELY TWO WEEKS PRIOR TO THIS OFFICE VISIT. PATIENT HAS HAD SIGNIFICANT SWELLING SINCE THEN. PATIENT DENIED ANY INSTABILITY. X-RAYS REVIEWED - WELL POSITIONED PROSTHESIS. RECORDS DATED (B)(6) 2016: PATIENT HAS HAD CHRONIC PAIN AND SWELLING SINCE FALLING 7 WEEKS

  Patient problems: Failure of Implant; Pain

  MAUDE report 6456545 ↗