MRH 6481-2-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327045284), received between Feb 7, 2019 and Oct 27, 2021 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2021Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT PRESENTED WITH INSTABILITY OF AN MRH CONSTRUCT. DR. SUSPECTED INFECTION, BUT TEST RESULTS WERE NOT CONCLUSIVE GIVEN THE PATIENT¿S COMORBIDITIES. NO COMPLAINTS HAVE BEEN FILED AGAINST THE PREVIOUS IMPLANTS, NO FURTHER INFO AVAILABLE."

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 12708587 ↗
• InjuryOct 25, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S RIGHT DISTAL FEMUR WAS REVISED DUE TO WEAR AND DEBRIS FROM THE INSERT AND SLEEVE. SURGEON HAS REQUESTED THAT AN ELEMENTAL ANALYSIS BE PERFORMED ON THE DEVICES, WHICH WILL BE RETURNED.

  Patient problems: Injury

  MAUDE report 9238825 ↗
• InjuryMay 21, 2019Degraded; Degraded

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO WEAR OF THE POLY COMPONENT. POSSIBLE CAUSE OR CONTRIBUTOR FOR WEAR NOT REPORTED. PATIENT'S ACTIVITY LEVEL IS UNKNOWN. PATIENT WAS REVISED TO POLY COMPONENT OF THE SAME CATALOG NUMBER. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury

  MAUDE report 8627589 ↗
• InjuryMar 20, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A NOTE AT THE BOTTOM OF THE SHEET REPORTS "REVISED FOR INSTABILITY AND POSSIBLE INFECTION". AN MRH KNEE CONSTRUCT WAS REVISED TO AN MRH/ GMRS KNEE CONSTRUCT.

  Patient problems: Ambulation or Postural Difficulties; Injury; Unspecified Infection

  MAUDE report 8436129 ↗
• InjuryFeb 7, 2019Material Deformation; Insufficient Device Problem Information; Material Deformation; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT DISTAL FEMUR WAS REVISED DUE TO WEAR AND DEBRIS FROM THE INSERT AND SLEEVE. SURGEON HAS REQUESTED THAT AN ELEMENTAL ANALYSIS BE PERFORMED ON THE DEVICES, WHICH WILL BE RETURNED. PATIENT WAS REVISED TO THE SAME DEVICES (DIFFERENT LOT NUMBERS).

  Patient problems: Injury

  MAUDE report 8314826 ↗