MRH 6481-3-216Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 07613327043808), received between Feb 23, 2018 and Aug 23, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A WASHOUT AND EXCHANGE OF POLY COMPONENTS, AXLE, AND ROTATING COMPONENT WAS PERFORMED ON THE PATIENT'S RIGHT HINGED KNEE DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 15280288 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR. PERFORMED AN ABOVE THE KNEE AMPUTATION, LEFT SIDE OF A PATIENT THAT HAD A GMRS DISTAL FEMORAL REPLACEMENT IN DUE TO INFECTION. THE PREVIOUS SURGERY WAS ON (B)(6) 2022 FOR AN INFECTION, HOWEVER THE KNEE BECAME INFECTED AGAIN.

  Patient problems: Ambulation or Postural Difficulties; Unspecified Infection

  MAUDE report 14951890 ↗
• InjurySep 1, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT UNDERWENT LEFT TOTAL KNEE REVISION DUE TO INFECTION ASSOCIATED WITH INTERNAL LEFT KNEE PROSTHESIS (B)(6) 2019. PATIENT UNDERWENT NEW REVISION OF LEFT TOTAL KNEE ARTHROPLASTY DUE TO PJI, ALL COMPONENTS CHANGED (B)(6) 2020.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 10478549 ↗
• InjuryJun 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED BY REP: "THE PATIENT. PRESENTED WITH LIMITED RANGE OF MOTION IN THE AFFECTED LEG, THE PLAN WAS TO USE A THINNER POLY INSERT AND ASSESS IF THAT WOULD IMPROVE THE ROM, GIVEN THE PATIENT'S MULTIPLE HEALTH ISSUES. NO FAILURES OR ISSUES WERE REPORTED AS TO THE COMPONENTS WHICH WERE SWAPPED OUT". REP REPORTED THAT THE DEVICES MAY BECOME AVAILABLE FOR RETURN, AND NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 8738099 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT UNDERWENT RIGHT TOTAL KNEE REPLACEMENT SEVERAL YEARS AGO (OUTSIDE OF CORS SCOPE). PATIENT UNDERWENT DISTAL FEMORAL REPLACEMENT AFTER A PERIPROSTHETIC FRACTURE (B)(6) 2018. PATIENT DEVELOPED A PERIPROSTHETIC JOINT INFECTIONS AND ALL MOBILE (BEARING) COMPONENTS [TIBIAL ROTATING COMPONENT AND INSERT, BUMPER INSERT, TIBIAL SLEEVE, AXLE, DISTAL FEMORAL BUSHINGS]WERE EXCHANGED (B)(6) 2018.

  Patient problems: Bone Fracture(s); Injury; Unspecified Infection

  MAUDE report 8568811 ↗
• MalfunctionFeb 23, 2018Device Operates Differently Than Expected; Scratched Material; Device Operates Differently Than Expected; Scratched Material

  AS REPORTED: "SURGEON WAS EXPLANTING NON-STRYKER TKA IMPLANTS SUBSEQUENT TO A PERIPROSTHETIC FRACTURE AND RECONSTRUCTING WITH A DISTAL FEMORAL GMRS CONSTRUCT. ALL IMPLANTS WERE ASSEMBLED ON THE BACK TABLE PRIOR TO IMPLANTATION. SURGEON FELT THAT MRH TIBIAL INSERT DID NOT ADEQUATELY ENGAGE/ LOCK INTO MRH BASEPLATE. ANOTHER INSERT WAS PROVIDED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7292644 ↗