MRH 6481-2-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327045208), received between Sep 25, 2018 and Apr 14, 2026 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2026Degraded; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION KNEE SURGERY - INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24870050 ↗
• InjuryOct 29, 2025Unstable; Adverse Event Without Identified Device or Use Problem; Unstable; Adverse Event Without Identified Device or Use Problem

  AS PER PSS IMPLANT REQUEST: POLIO , RIGHT KNEE MRH IN SITU. PATIENT HAS MRH IN SITU S1 BASEPLATE, SMALL FEMUR, 10MM POLY PATIENT IS UNABLE TO MAINTAIN A STRAIGHT LEG DUE TO POLIO WASTING OF QUADS. SHE USED TO RELY ON SLIGHT KNEE HYPER EXTENSION TO MAINTAIN A WEIGHT BEARING STRUT FOR INDEPENDENT AMBULATION. I WOULD LIKE A MODIFICATION OF THE TIBIAL ROTATING COMPONENT TO ALLOW 10 DEGREES HYPER EXTENSION IN ORDER TO ALLOW PATIENT TO WEIGHT BEAR. POLIO RIGHT KNEE OA PATIENT UNDERWENT MRH FOR OSTEOARTHRITIS 16/07/2024. RECOVERED WELL BUT KNEE KEEPS GIVING WAY ON WEIGHT ACCEPTANCE. PHYSIO AND BRACING ATTEMPTED IN THE PAST. PATIENT UNABLE TO MAINTAIN STRAIGHT LEG WITH QUADS WASTING. CURRENT MRH DOES NOT ALLOW HYPER EXTENSION TO LOCK KNEE USING GROUND REACTION FORCE. HOPEFULLY REVISING ONLY THE ROTATING COMPONENT OF THE STRYKER MRH. PER DESIGN CONCEPT: PATIENT USED TO RELY ON SLIGHT KNEE HYPER EXTENSION TO MAINTAIN A WEIGHT BEARING STRUT FOR INDEPENDENT AMBULATION. PATIENT IS LOW DEMAND.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 23418239 ↗
• 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 15788318 ↗
• 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 12708584 ↗
• 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 11691470 ↗
• InjuryApr 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAS A HISTORY OF REVISIONS AT OTHER HOSPITALS OF WHICH ALL DETAILS I DO NOT HAVE ACCESS TO. WE ARE TOLD THAT THE FIRST TKR CASE WAS DONE IN 2014- PATIENT NOT SURE AND NO RECORDS. IT WAS REVISED (B)(6) 2019. GMRS DISTAL FEMUR/ MRH HINGE KNEE IMPLANTED. IN (B)(6) 2020 PATIENT TREATED FOR DIAR AGAIN. PATIENT PRESENTED ON THURSDAY EVENING (B)(6) 2020 WITH A DISLOCATED PROSTHESIS. HE APPARENTLY WAS ONLY GETTING UP FROM A SEATED POSITION INTO THE STANDING POSITION WHEN IT DISLOCATED. DOCTOR CONTACTED ME AT 9:22PM TO ASK FOR ASSISTANCE FOR THE CASE WHICH DR. WAS GOING TO ATTEMPT TO REDUCE AT AROUND MIDNIGHT. CASE ONLY STARTED AT 1:45AM AND CONCLUDED SUCCESSFULLY AT 2:15AM. DR DID SAY THAT PERHAPS A THICKER INSERT WOULD HAVE BEEN HANDY HOWEVER DUE TO THE LATE NATURE OF PATIENT PRESENTING AND URGENCY TO REDUCE- TIME WAS OF THE ESSENCE AND THAT LUXURY OF A POLY INSERT UPGRADE WAS NOT AN AVAILABLE OPTION. ISSUE WAS NOTED VIA X-RAY, ITS SHOWED CLEAR DISLOCATION- SEE PHOTO PRE OP AND X RAYS.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9913872 ↗
• InjuryOct 22, 2019Material Deformation; Material Deformation

  IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SURGERY DUE TO FRACTURE. THE PATIENT HAD AN ORIGINAL IMPLANT IN 2013, WHICH WAS REVISED IN (B)(6) 2017. THIS FRACTURED AGAIN IN (B)(6) 2019 AND THIS PI IS FOR THE OPERATION CARRIED LAST WEEK.

  Patient problems: Injury

  MAUDE report 9219307 ↗
• InjuryAug 19, 2019Degraded; Material Deformation; Degraded; Material Deformation

  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: Ambulation or Postural Difficulties; Injury

  MAUDE report 8905516 ↗
• 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 8436130 ↗
• InjurySep 25, 2018Break; Fracture; Loss of Osseointegration; Break; Fracture; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING OF THE FEMUR AND TIBIA, AS WELL AS A BROKEN FEMORAL STEM AT THE STEM/ OFFSET BOLT INTERFACE. REP REPORTED THE PATIENT'S ENTIRE KNEE WAS REVISED.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7908433 ↗