MRH 6481-1-121Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327045161), received between May 20, 2019 and May 27, 2026 — classified as 11 injuries.

The most frequently reported specific device problem is “Fracture” (6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 27, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: A FRACTURE OF THE FEMORAL COMPONENT OF THE GMRS K-TEP WAS DETECTED DURING A PREOPERATIVE X-RAY. REVISION ON (B)(6) 2026.

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 25302973 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: WOUND DEHISCENCE. SILVADENE, NO INFECTION. NO COMPONENTS REMOVED.

  Patient problems: Wound Dehiscence

  MAUDE report 22724389 ↗
• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR THE ORIF. INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: R PERIPROSTHETIC TIBIAL FRACTURE. REQUIRED ORIF ON (B)(6) 2011. DEVELOPED INSTABILITY. FEMORAL BUMPER, BUSHINGS, TIBIAL INSERT, TIBIAL SLEEVE, AXLE, TIBIAL BUSHINGS REVISED (B)(6) 2012.

  Patient problems: Bone Fracture(s)

  MAUDE report 22713472 ↗
• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22683202 ↗
• InjuryMar 27, 2024Fracture; Fracture

  REVISION OF MRH KNEE TO DISTAL FEMUR GMRS. CAUSE OF REVISION FRACTURED FEMORAL COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 18987932 ↗
• InjuryFeb 15, 2024Fracture; Loss of Osseointegration; Fracture; Loss of Osseointegration

  REVISION OF PROXIMAL TIBIA GMRS, WITH MRH FEMUR AS PATIENT WAS SYMPTOMATIC. FOUND ON INVESTIGATION THAT MRH FEMUR HAD BROKEN AT CONDYLE.

  Patient problems: Insufficient Information

  MAUDE report 18711128 ↗
• InjuryFeb 12, 2024Loss of Osseointegration; Loss of Osseointegration

  AS REPORTED: "RIGHT MRH REVISION. PT. PRESENTED WITH COMPLAINTS OF FEMORAL PAIN. IMAGING DETERMINED THE MRH FEMORAL CONSTRUCT WAS LOOSE, REQUIRING REVISION. ORIGINAL DOS IS UNKNOWN. REVISED THE FEMUR TO THE COMPONENTS LISTED IN THE ATTACHED SURGERY SHEET. TIBIAL COMPONENTS WERE LEFT IN-SITU, NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 18683640 ↗
• InjurySep 21, 2021Fracture; Fracture

  IT WAS REPORTED BY THE SALES REP THAT THE MRH FEMORAL COMPONENT RIGHT SIDE BROKE SO IT WAS REPLACED WITH A NEW ONE.

  Patient problems: Insufficient Information

  MAUDE report 12505693 ↗
• InjuryDec 1, 2020Fracture; Unstable; Loss of Osseointegration; Fracture; Unstable; Loss of Osseointegration

  THE CEMENTED SHAFT WAS SEPARATED FROM THE FEMUR. THE ITEM WAS EXPLANTED ON (B)(6) AND REPLACED BY A GMRS FEMUR (DIATAL FEMORAL REPLACEMENT). INITIAL IMPLANTATION TOOK PLACE IN 2017. SINCE ONE WEEK INSTABILITY WAS NOTICEABLE.

  Patient problems: Inadequate Osseointegration; Joint Laxity; Pain

  MAUDE report 10926754 ↗
• InjuryOct 10, 2019Crack; Fracture; Crack; Fracture

  AS REPORTED: "PATIENT COMPLAINED TO SURGEON THAT SOMETHING FELT LOOSE. THE PRE-OP X- RAYS DIDN'T APPEAR TO SHOW ANYTHING CONCERNING. UPON INCISION AND EXPOSURE THE LATERAL ASPECT OF MRH IMPLANT (FEMUR) APPEARED TO HAVE A CRACK RUNNING ACROSS THE WHOLE CONDYLE. WHEN TRYING TO REMOVE THE IMPLANT THE ENTIRE CONDYLE OF THE MRH IMPLANT BROKE OFF."

  Patient problems: Failure of Implant; Injury

  MAUDE report 9176797 ↗
• InjuryMay 20, 2019Osseointegration Problem; Osseointegration Problem

  LOOSENING OF THE MRH PROSTHESIS IN THE FEMORAL AREA. STEM LOOSENED FROM FEMUR.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 8623680 ↗