MRH 6481-2-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327045246), received between Mar 20, 2019 and Jul 31, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Degraded” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2023Degraded; Naturally Worn; Degraded; Naturally Worn

  FIRST REVISION TO DISTAL FEMUR DUE TO MRH KNEE FEMORAL BUSHING P.E. WEAR, + BROKEN METALLIC MECHANICAL FAILURE OF LATERAL FEMORAL CONDYLE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17422642 ↗
• InjuryJul 31, 2023Degraded; Naturally Worn; Degraded; Naturally Worn

  FIRST REVISION TO DISTAL FEMUR DUE TO MRH KNEE FEMORAL BUSHING P.E. WEAR, + BROKEN METALLIC MECHANICAL FAILURE OF LATERAL FEMORAL CONDYLE.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17422641 ↗
• 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." SPOKE TO REP, WHO PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 12708590 ↗
• 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." SPOKE TO REP, WHO PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Laxity; Unspecified Infection

  MAUDE report 12708588 ↗
• InjuryApr 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A PATIENT SPECIFIC SOLUTIONS REQUEST WAS RECEIVED FOR THE PATIENT'S RIGHT DISTAL FEMUR WITH NOTES: "UNDERWENT CONSTRAINED TKA WITH STRYKER COMPONENTS AND AFTER INITIAL POSTOP PERIOD OF DOING WELL HAS HAD PERSISTENT OSTEOLYSIS, PAIN AND DECREASING FUNCTION. ALLERGY TESTING REVEALED NICKEL ALLERGY AND MULTIPLE BLOOD AND ASPIRATIONS OF THE JOINT HAVE BEEN NEGATIVE FOR INFECTION." A NICKEL FREE DISTAL FREE FEMUR IMPLANT IS BEING REQUESTED WITH A PLANNED DATE OF SURGERY (B)(6) 2021. UPDATE: "THE REASON FOR REVISION IS METAL SENSITIVITY."

  Patient problems: Inflammation; Pain

  MAUDE report 11691468 ↗
• InjuryApr 19, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  A PATIENT SPECIFIC SOLUTIONS REQUEST WAS RECEIVED FOR THE PATIENT'S RIGHT DISTAL FEMUR WITH NOTES: "UNDERWENT CONSTRAINED TKA WITH STRYKER COMPONENTS AND AFTER INITIAL POSTOP PERIOD OF DOING WELL HAS HAD PERSISTENT OSTEOLYSIS, PAIN AND DECREASING FUNCTION. ALLERGY TESTING REVEALED NICKEL ALLERGY AND MULTIPLE BLOOD AND ASPIRATIONS OF THE JOINT HAVE BEEN NEGATIVE FOR INFECTION." A NICKEL FREE DISTAL FREE FEMUR IMPLANT IS BEING REQUESTED WITH A PLANNED DATE OF SURGERY (B)(6) 2021. UPDATE: "THE REASON FOR REVISION IS METAL SENSITIVITY."

  Patient problems: Foreign Body Reaction; Inflammation; Pain

  MAUDE report 11691466 ↗
• 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 8436938 ↗
• 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 8436202 ↗