Arthrex® AR-623-63Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867256651), received between Apr 27, 2018 and Apr 27, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment Of Device Component” (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.

• InjuryApr 27, 2018Detachment Of Device Component; Device Or Device Fragments Location Unknown

  IT WAS REPORTED THAT DURING A RIGHT TOTAL KNEE ARTHROPLASTY PROCEDURE, THE WASHER THAT HOLDS THE EXTERNAL ROTATION ADJUSTMENT TOGETHER CAME OFF AND COULD NOT BE LOCATED. AN X-RAY (A/P AND LATERAL) WAS TAKEN AND THE WASHER COULD NOT BE SEEN. THE CASE WAS COMPLETED AND THE OUTCOME WAS NOT AFFECTED. PATIENT WAS MALE. FOLLOW-UP INVESTIGATION: THE AR-62-63 LOT NUMBER IS 37621632. THE DEVICE PART INITIALLY REFERRED TO AS A WASHER HAS BEEN CONFIRMED TO BE SUBPART C13345-01 "CAP" AS REFERRED TO ON THE DEVICE ASSEMBLY INSTRUCTIONS DIAGRAM FOR AR-623-63.

  Patient problems: Foreign Body In Patient

  MAUDE report 7467848 ↗