MRS 6485-2-608Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327048247), received between Jul 27, 2018 and Jul 27, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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.

• MalfunctionJul 27, 2018Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  PRIMARY PROCEDURE, RIGHT KNEE. IT WAS REPORTED THAT AFTER TRIALING, COMPONENTS WERE CEMENTED IN WHEN IT WAS DISCOVERED THAT THE IMPLANTS WERE MUCH LONGER THAN THE TRIALS (TRIALS AND IMPLANTS WERE MATCHED). A SURGICAL DELAY OF 1 HOUR WAS CAUSED BY THE NEED TO EXPLANT ALL DEVICES AND RE-IMPLANT DEVICES WHICH FIT THE PATIENT. NO TOURNIQUET WAS USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7725803 ↗