MRH 6481-3-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327043860), received between Aug 1, 2018 and May 5, 2021 — classified as 2 injuries, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. ALL POLY COMPONENTS WERE REVISED, ALL METAL COMPONENTS WERE REMOVED, WASHED AND STERILIZED, AND RE-IMPLANTED AFTER SURGEON WAS NOTIFIED THAT THIS WAS OFF-LABEL. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11776016 ↗
• MalfunctionJun 18, 2019Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  THE FOLLOWING WAS REPORTED: DURING IMPLANTATION OF FINAL MRH TIBIAL INSERT, THE INSERT FAILED TO LOCK TO THE TIBIAL BASEPLATE ANTERIORLY. AFTER REPEATED ATTEMPTS TO SEAT THE INSERT, THE DECISION WAS MADE TO INSERT THE NEXT LARGER IMPLANT [6481-3-324]. THIS IMPLANT SEATED PROPERLY. IT WAS FURTHER REPORTED THAT EXTRA TIME ADDED TO CASE WAS 15 MINUTES AND NO PATIENT HARM OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8707619 ↗
• InjuryAug 1, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION BEYOND THAT WHICH HE PROVIDED ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7739569 ↗