Arthrex® AR-516-5RRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867109353), received between May 22, 2017 and May 22, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Failure To Adhere Or Bond” (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.

• InjuryMay 22, 2017Failure To Adhere Or Bond; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT ON (B)(6) 2015 A PATIENT HAD UNDERGONE A TKA PROCEDURE DURING WHICH THE PATELLA WAS NOT RESURFACED. ON (B)(6) 2017 THE SURGEON PERFORMED A REVISION TKA DUE TO TIBIAL LOOSENING AND PAIN. DURING THE REVISION THE FOLLOWING DEVICES WERE EXPLANTED: TIBIAL TRAY, AR-503-TTTE, LOT 1315462, FEMORAL IMPLANT, AR-516-5R, LOT 108761425 AND BEARING IMPLANT, AR-513-BE09, LOT 113601402. THE REVISION WAS COMPLETED USING ANOTHER MANUFACTURER'S PRODUCT. THE OPERATIVE REPORTS AND MEDICAL RECORDS INDICATE PATIENT IS MORBIDLY OBESE (BMI OF (B)(6)) WHICH IS CONTRAINDICATED FOR THIS PRODUCT.

  Patient problems: Pain

  MAUDE report 6580998 ↗