MRH 6481-2-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 07613327045253), received between Dec 28, 2018 and May 21, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Fracture” (7 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2025Unstable; Unstable

  REVISION OF LEFT MRH KNEE FOR REPORTED PATELLA INSTABILITY. SURGEON MODIFIED PROSTHESIS BY BURRING AXLE AND CEMENTING SYNTHETIC TAPE INTO AXLE.

  Patient problems: Joint Laxity

  MAUDE report 22066563 ↗
• InjuryAug 22, 2024Fracture; Fracture

  BREAKAGE OF THE COUPLING MECHANISM (COUPLING AXIS) 10 YEARS AFTER IMPLANTATION.

  Patient problems: Insufficient Information

  MAUDE report 20039219 ↗
• InjuryApr 18, 2024Fracture; Fracture

  THE FOLLOWING WAS REPORTED: MRH AXLE BROKEN IN THE MIDDLE. NO VIOLENCE/NO TRAUMA - ACCORDING TO THE DOCTOR, THE AXLE BROKE WITHOUT ANY EXTERNAL INFLUENCE WHEN THE KNEE WAS BENT. PATIENT HAS PRESENTED HIMSELF AT THE CONSULTATION. LOUD NOISE WHEN BENDING. ACCORDING TO THE PATIENT, THERE WAS ONLY A POPPING SOUND. THE NOW DEFECTIVE SYSTEM WAS INSTALLED IN ANOTHER CLINIC IN 2016. HERE TODAY ONLY THE REVISION PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 19130566 ↗
• InjuryJan 5, 2024Fracture; Fracture

  REVISION OF DISTAL FEMUR GMRS, DISCOVERED BROKEN AXEL DURING SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 18453032 ↗
• InjuryJan 12, 2023Fracture; Noise, Audible; Fracture; Noise, Audible

  THE GMRS AXLE SNAPPED IN HALF WHILE IMPLANTED IN THE PATIENT. NO OTHER COMPONENTS WERE DAMAGED. THERE WAS NO ACCIDENT OR INJURY LEADING TO THE EVENT. THE PATIENT EXPERIENCED CLICKING IN HIS KNEE AND WENT IN FOR IMAGING. CT REVEALED A BROKEN AXLE AND A REVISION SURGERY WAS REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 16143528 ↗
• InjuryNov 14, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION OF MRH INITIALLY DONE IN 2012. SURGEON OUTLINED REASON FOR REVISION AS METALOSIS INFECTION. THE SURGEON REMOVED ALL MRH IMPLANTS AND IMPLANTED A COMPETITOR SPACER

  Patient problems: Unspecified Infection

  MAUDE report 15788327 ↗
• InjuryOct 14, 2022Break; Fracture; Break; Fracture

  THE CUSTOMER REPORTED A "BROKEN AXLE" TO THE COMPETENT AUTHORITY.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15604778 ↗
• InjurySep 16, 2022Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT REQUIRED A REVISION OF THE COMPONENTS. IT WAS FURTHER REPORTED THAT THE PATIENT SUFFERED AN ACUTE FALL WITH HYPEREXTENSION IN MARCH 2022. AN AUDIBLE CLICKING WAS REPORTED AS A RESULT. PATIENT EXPERIENCED 'INSTABILITY' IN JULY 2022.

  Patient problems: Fall; Joint Laxity

  MAUDE report 15436364 ↗
• 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 12708589 ↗
• InjuryOct 14, 2021Fracture; Fracture

  STRYKER REP REPORTED A REVISION SURGERY. THE PATIENT HAD A GMRS DISTAL FEMUR IN SITU. IT WAS FOUND THAT THE AXLE OF THE KNEE COMPONENT HAD BROKEN. NEW LINKAGE ITEMS WERE REPLACED DURING THE OPERATION.

  Patient problems: Insufficient Information

  MAUDE report 12632725 ↗
• 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 11691469 ↗
• InjuryApr 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED HER HINGE PROSTHESIS. FEMUR WAS LOOSE. PATIENT REVISION.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8484435 ↗
• 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 8436278 ↗
• InjuryDec 28, 2018Break; Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT TOTAL DISTAL FEMUR WAS REVISED AFTER PATIENT COMPLAINT OF PAIN. INTRA-OPERATIVELY, THE AXLE WAS FOUND TO BE BROKEN. NO OTHER CAUSE OR CONTRIBUTOR TO PAIN WAS REPORTED.

  Patient problems: Injury

  MAUDE report 8204649 ↗