Arthrex® AR-513-BH13Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107588), received between Sep 4, 2018 and Sep 4, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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.

• InjurySep 4, 2018Material Fragmentation; Loose or Intermittent Connection

  IT WAS REPORTED THE IMPLANT WAS EXPLANTED PER THE SURGEONS DECISION. THE DOCTOR SAW A SLIGHT SIGN OF OSTEOLYSIS ON THE X-RAY. THE PATIENT HAD NO ISSUES WITH THE ORIGINAL IMPLANT AND WAS NOT IN ANY PAIN. HE MADE THIS DECISION BASED ON THE NEWER IMPLANT WOULD LAST LONGER AND BE POTENTIALLY MORE BENEFICIAL FOR THE PATIENT. THE PATIENT HAD NO COMPLAINTS AND WAS NOT IN ANY PAIN. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2014. THE SURGERY WAS SUCCESSFUL AND THE PATIENT WAS FINE. THE DOCTOR IS RETURNING THE IMPLANT FOR EXAMINATION. THIS WAS A (B)(6) MALE PATIENT. THE QUALITY OF BONE AND AGE OF THE PATIENT WAS NOT KNOWN AT THE TIME OF THE CALL. ADDITIONAL INFORMATION OBTAINED 8/13/2018: THE SURGEON TOOK AN X-RAY OF THE PREVIOUSLY PERFORMED TKA OF PATIENT¿S KNEE AND DISCOVERED A SLIGHT SIGN OF OSTEOLYSIS ON THE PATIENT¿S X-RAY. IT WAS REPORTED THAT THE PATIENT WAS NOT HAVING ANY PAIN OR ISSUES WITH THESE ORIGINAL IMPLANTS. THE SURGEON THOUGHT IT WAS POSSIBLE THAT THE POST FROM THE POLY BEARING PS MIGHT BE LOOSE AND POSSIBLY ALLOWED SOME DEBRIS TO MIGRATE BELOW THE TIBIAL TRAY WHICH MIGHT HAVE LED TO THE OSTEOLYSIS. DURING THE (B)(6) 2018 REVISION PROCEDURE THE SURGEON FOUND NO SIGN OF THE PS

  Patient problems: Osteolysis

  MAUDE report 7841922 ↗