Arthrex® AR-516-8LRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867109407), received between Feb 27, 2017 and Feb 27, 2017 — 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

Recent adverse event reports

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

• InjuryFeb 27, 2017Device Slipped

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT UNDERWENT A LEFT TKA PROCEDURE. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION LEFT TKA DUE TO UNEXPLAINED PAIN AND LOOSE TIBIA. DURING THE REVISION PROCEDURE THE SURGEON EXPLANTED THE (TIBIAL TRAY AR-503-TTTJ, LOT 1251021, ((B)(4)), BEARING IMPLANT AR-513-BJ13, LOT 113601404 ((B)(4)), FEMORAL IMPLANT AR-516-8L, LOT 108761335 ((B)(4)) AND PATELLA IMPLANT AR-504-PSC9, LOT 113601437 ((B)(4)). TO COMPLETE THE PROCEDURE THE SURGEON USED ANOTHER MANUFACTURER'S PRODUCT. PATIENT WAS A MALE, (B)(6). PATIENT WAS IN THE OBESE RANGE BY BMI AT THE TIME OF INITIAL WHICH IS CONTRAINDICATED FOR TKA. PATIENT MEDICAL RECORDS DATED (B)(6) 2016 NOTED: LEFT KNEE X-RAY FINDINGS - PROSTHESIS IN PLACE IN PROPER ANATOMICAL ALIGNMENT WITHOUT ROTATION, LOOSENING OR STRESS SHIELDING. RECORDS NOTED PATIENT WOULD START WEIGHT LOSS PROGRAM TO SEE IF IT WOULD MAKE ANY DIFFERENCE. PATIENT MEDICAL RECORDS DATE (B)(6) 2016 NOTED: PATIENT HAD A I&D OF HEMATOMA 5/18/15. PATIENT HAS HAD EMBOLIZATIONS X3, PATIENT WAS NOTED TO HAVE DECREASED MOBILITY, PAIN WITH SLEEPING, WALKING, STAIRS AND ALL WEIGHT BEARING ACTIVITIES. EXAMINATION OF THE LEFT KNEE DEMONSTRATED SWELLING AN

  Patient problems: Edema; Hematoma; Limited Mobility Of The Implanted Joint; Pain; Swelling

  MAUDE report 6360433 ↗