Arthrex® AR-513-BJ08Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00888867107632), received between May 11, 2018 and May 11, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Mechanics Altered” (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 11, 2018Migration or Expulsion of Device; Mechanics Altered

  IT WAS REPORTED BY THE PATIENT'S ATTORNEY THAT THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2015. THE FOLLOWING ARTHREX DEVICES WERE IMPLANTED AT THE TIME OF PROCEDURE:AR-503-TTTJ TIBIAL TRAY LOT 108761232;AR-513-BJ08 TIBIAL BEARING LOT 113401345;AR-516-8R FEMORAL IMPLANT LOT 108761339;AR-504-PSD0 PATELLA IMPLANT LOT 113601323.ON (B)(6) 2015, THE PATIENT HAD A FOLLOW UP VISIT WITH THE ORIGINAL SURGEON WITH COMPLAINTS OF SWELLING AND PAIN IN THE RIGHT KNEE. RADIOGRAPHS WERE TAKEN THEY SHOWED THE TIBIAL POLY INSERT WAS DISLODGED. THE SURGEON INFORMED THE PATIENT IT COULD TAKE UP TO SIX MONTHS TO HEAL AND REQUESTED HE FOLLOW UP IN THREE MONTHS. THE PATIENT RETURNED TO THE ORIGINAL SURGEON ON (B)(6) 2015. X-RAYS WERE TAKEN AND REVEALED THAT THE POLY-INSERT WAS 50% SUBLUXED ANTERIORLY AND HAD PROGRESSIVELY MIGRATED OVER THE PAST SEVERAL MONTHS. THE SURGEON BELIEVED THAT THE LOCKING MECHANISM OF THE POLYETHYLENE WAS NOT ENGAGED. THE SURGEON RECOMMENDED PERFORMING A POLY-INSERT EXCHANGE. ON (B)(6) 2015, THE PATIENT SOUGHT A SECOND OPINION FROM A DIFFERENT SURGEON. THE NEW SURGEON RECOMMENDED A TOTAL REVISION OF THE RIGHT KNEE DUE TO THE ORIGINAL SURGEON'S IMPROPER SIZIN

  Patient problems: Joint Dislocation; Pain; Swelling

  MAUDE report 7506200 ↗