MRH 6481-3-112Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327045321), received between Aug 1, 2018 and Aug 5, 2025 — classified as 7 injuries.

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

• InjuryAug 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(6) INDICATES THE FOLLOWING: PROSTHETIC JOINT INFECTION REQUIRED I&D. NO COMPONENTS WERE REMOVED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22713671 ↗
• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. RIGHT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22683200 ↗
• InjuryJul 31, 2025Unstable; Unstable

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: L KNEE INSTABILITY. NO COMPONENTS REPORTED IN SCOPE OF STUDY REMOVED.

  Patient problems: Joint Laxity

  MAUDE report 22680681 ↗
• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  THE FOLLOWING WAS REPORTED: "ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE."

  Patient problems: Inadequate Osseointegration

  MAUDE report 22680521 ↗
• InjuryMar 18, 2024Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  REVISION OF DISTAL FEMORAL GMRS WITH MRH TIBIA. DIAGNOSIS FOR REVISION WAS LYSIS AND SUSPECTED FEMORAL STEM LOOSENING. INTRA-OP, THE SURGEON COMMENTED THAT THE TIBIAL CONSTRUCT WAS LOOSE AND ALSO NEEDED TO BE REMOVED. WHEN REMOVING THE TIBIAL CONSTRUCT, THE SURGEON COMMENTED THAT THE STEM WAS NOT TIGHT ON THE BASEPLATE AND WAS FREELY MOVING (UNTHREADING). ISSUE NOTICED AFTER PRIMARY PROCEDURE, PRIOR TO REVISION PROCEDURE.

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Osteolysis

  MAUDE report 18921740 ↗
• InjuryJan 30, 2020Insufficient 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: Injury; Unspecified Infection

  MAUDE report 9648133 ↗
• InjuryAug 1, 2018Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO ASEPTIC LOOSENING. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND FURTHER INFORMATION BEYOND THAT WHICH HE PROVIDED ARE NOT AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 7739504 ↗