MRH 6481-1-101Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327045123), received between Jan 25, 2021 and Feb 16, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 16, 2026Fracture

  PATIENT WAS BROUGHT TO SURGERY FOR A REVISION HER RIGHT GMRS PROXIMAL TIBIAL REPLACEMENT WITH MRH FEMUR. INITIAL SURGERY WAS DONE IN 2019. PATIENT STATED THAT APPROXIMATELY TWO WEEKS AGO SHE FELT A POP IN HER KNEE, THEN INSTANT INSTABILITY. THE DOCTOR THOUGHT SHE POSSIBLY BROKE THE AXLE IN THE HINGE COMPONENT. UPON DISSECTION, IT WAS NOTED THAT THE LATERAL FEMORAL CONDYLE HAD BROKEN OFF OF THE MRH FEMORAL COMPONENT. PATIENT HAD TO UNDERGO FULL REVISION OF THE FEMORAL COMPONENT WITH STEM. PATIENT WAS WALKING AND HEARD A ¿POP¿. NO EXTRANEOUS CAUSE WAS REPORTED.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 24344326 ↗
• InjuryMay 22, 2023Fracture; Fracture

  PATIENT REPORTED FOR REVISION SURGERY DUE TO QUERY OF FAILED MRH COMPONENT. CONFIRMED DURING SURGERY THAT MRH DISTAL FEMUR AND STEM EXTENDER HAD BROKEN AND DETACHED. IMPACT: REVISION SURGERY CONVERT MRH TO DISTAL FEMUR GMRS. PROCEDURE: MRH TO PROXIMAL FEMUR GMRS RECONSTRUCTION REVISION.

  Patient problems: Insufficient Information

  MAUDE report 16973536 ↗
• InjurySep 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO DISLOCATION OF THE PATIENT'S RESURFACED PATELLA FOLLOWING A FALL. ONLY THE POLY COMPONENTS WERE REVISED PROPHYLACTICALLY AGAINST INFECTION - NO OTHER IMPLANTS REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 15425694 ↗
• InjuryMay 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6), 2017, SCOPIO TS WAS REVISED TO MRH. THERE WAS NO ISSUE IN MARCH. ON (B)(6), 2021, PATIENT VISITED HOSPITAL SINCE HER LEG WAS JERKY. FEM COMPONENT WAS DISENGAGED FROM STEM. IT WILL BE REVISED ON (B)(6), 2021.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11838433 ↗
• InjuryMar 30, 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.

  Patient problems: Inflammation; Pain

  MAUDE report 11591246 ↗
• InjuryJan 25, 2021Fracture; Fracture

  ON (B)(6)2007, A FEMALE PATIENT UNDERWENT TKA DUE TO OSTEOARTHRITIS OF THE KNEE (RIGHT SIDE) CAUSED BY RHEUMATOID ARTHRITIS. ON (B)(6)2020 THE PATIENT UNDERWENT REVISION SURGERY DUE TO BROKE OF THE IMPLANT. IT IS CONSIDERED THAT THE WEAR OF POLYETHYLENE CAUSES OSTEOLYSIS, WHICH STRESSES THE IMPLANT AND CAUSES THE STEM TO BREAK. COBALT CHROMIUM, WHICH NORMALLY DOES NOT BREAK EASILY, HAS BROKEN, SO PLEASE INVESTIGATE THE CAUSE.

  Patient problems: Failure of Implant; Insufficient Information; Osteolysis

  MAUDE report 11223769 ↗