MRH 6481-2-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 07613327045260), received between Dec 11, 2018 and May 19, 2026 — classified as 12 injuries.

The most frequently reported specific device problem is “Degraded” (3 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF FEMUR DISTAL FEMUR GMRS AND TOTAL HIP REPLACEMENT (NOT STRYKER PRODUCTS) INSITU. NO REPORTED ISSUE WITH STRYKER DEVICES.

  Patient problems: Insufficient Information

  MAUDE report 25213629 ↗
• InjuryOct 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PT. PRESENTED WITH WOUND-DEHISCENCE OF HIS SURGICAL WOUND FOLLOWING AN I&D AND COMPONENT-SWAP OF HIS LEFT KNEE ON (B)(6) 2022. DR. PERFORMED ANOTHER EXTENSIVE I&D AND COMPONENT-SWAP, ALONG WITH SOME SOFT-TISSUE REPAIR. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES.

  Patient problems: Wound Dehiscence

  MAUDE report 15698102 ↗
• InjuryAug 8, 2022Degraded; Degraded

  IT WAS REPORTED THAT THE SURGEON REVISED THE AXLE BUSHINGS AND BUMPER AS A RESULT OF EXCESSIVE WEAR.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15188432 ↗
• InjuryMay 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PT. HAS SUFFERED FROM A CHRONIC INFECTION OF THE RIGHT-KNEE FOLLOWING MULTIPLE SURGERIES. PERFORMED AN EXTENSIVE I&D AND SWAPPED OUT SOME (B)(6) COMPONENTS AS PER I&D PROTOCOL. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES."

  Patient problems: Unspecified Infection

  MAUDE report 14344623 ↗
• InjuryNov 2, 2021Fracture; Unstable; Fracture; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "PRESENTED RECENTLY WITH AN ¿UNSTABLE/WOBBLY KNEE¿, FOLLOWING A FALL. PT. MANAGED TO BREAK THE 0-DEGREE BUMPER OF HER GMRS/MRH CONSTRUCT. ALL ¿UHMWPE¿ COMPONENTS WERE SWAPPED OUT, ALL METAL COMPONENTS WERE RETAINED/LEFT IN-SITU. NO COMPLAINTS HAVE BEEN FILED AGAINST THE IMPLANTS THEMSELVES." REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 12739252 ↗
• 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 12708585 ↗
• 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 11691467 ↗
• InjuryDec 10, 2020Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT HAD PAIN. X-RAYS SHOWED POTENTIAL DAMAGE TO BUMPER AND BUSHINGS. SURGEON PERFORMED POLY SWAP TO EXCHANGE THE SLEEVE, INSERT, ROTATING COMPONENT, TWO BUSHINGS, AXLE AND BUMPER." RIGHT SIDE. SPOKE TO REP, WHO PROVIDED A PICTURE OF THE EXPLANTS AND X-RAYS. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 10987632 ↗
• 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 AVAILABLE.

  Patient problems: Injury

  MAUDE report 8627457 ↗
• 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 8436128 ↗
• InjuryJan 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD COMPLAINED OF SOME PAIN. [SURGEON] EXAMINED IMPLANTS, AND PATIENT'S FEMUR AND TIBIA WERE SOLID [WELL-FIXED]. HE EXCHANGED THE BUSHINGS, LINER, ROTATING HINGE BUMPER AND SLEEVE. THE SLEEVE DID SHOW SOME DARKENING OF IMPLANT FROM ROTATING HINGE ACTIVITY". PATIENT IS VERY ACTIVE (WORKS STANDING UP EVERY DAY). SURGEON DOES NOT KNOW CAUSE OF PAIN AND WILL REFER THE PATIENT TO A LARGER INSTITUTION IF PAIN IS NOT RESOLVED.

  Patient problems: Injury; Pain

  MAUDE report 8253365 ↗
• InjuryDec 11, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION (INFECTING MICROORGANISM NOT IDENTIFIED). 9 OUT OF 10 OF THE DEVICES IN AN MRH CONSTRUCT WERE REVISED (A CEMENTED STEM WAS NOT REVISED).

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8153016 ↗