MRH 6481-3-313Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327043846), received between May 1, 2019 and Jan 28, 2026 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 28, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. ALL COMPONENTS EXCEPT THE BASEPLATE, FEMORAL COMPONENT, WEDGE AND STEMS WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 24203380 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT HAD AN INDEX LEFT TKA OUTSIDE OF CORS SCOPE. PATIENT HAD MULTIPLE PJIS AND REVISIONS OUTSIDE CORS SCOPE. ON (B)(6) 2022. PATIENT UNDERWENT REVISION FOR PJI WITH TOTAL FEMUR. (AT THIS TIME GETS INCLUDED INTO CORS). THE PATIENT DEVELOPED PJI AGAIN AND WAS REVISED ON (B)(6) 2024.ALL COMPONENTS WERE EXCHANGED. BUT WITH OFF-LABEL USE COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 23836080 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE END USER HAS REPORTED THAT AN UNEXPECTED ISSUE WAS OBSERVED WITH OPERATED KNEE 29 DAYS AFTER A GMRS SURGERY PERFORMED ON (B)(6) 2025. AT THIS TIME, THE CAUSE OF THE INCIDENT HAS NOT YET BEEN DETERMINED. THE SURGEON HAS ADVISED THAT THE PATIENT WILL UNDERGO A REVISION PROCEDURE TO DIRECTLY ASSESS THE SITUATION AND DETERMINE THE UNDERLYING CAUSES.

  Patient problems: Insufficient Information

  MAUDE report 23022445 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS IS FOR AMPUTATION OF THE PATIENT'S RIGHT LEG ON (B)(6) 2024. AS REPORTED: "WE DID AN EXCHANGE OF MOVEABLE PARTS ON MARCH 7TH BECAUSE OF INFECTION AND THEY DID A FLAP. AS OF YESTERDAY THE AMPUTATED HIS LEG AND EVERYTHING IS REMOVED." REP CONFIRMED AMPUTATION WAS DUE TO ONGOING INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 19089961 ↗
• InjuryMay 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION ON (B)(6) 2022. THE PATIENT HAD AN INDEX LEFT TKA OUTSIDE OF CORS SCOPE. THE PATIENT DEVELOPED PJI IN THE LEFT KNEE AND UNDERWENT REVISION WITH A GMRS SYSTEM FOR PJI WITH ALL COMPONENTS EXCHANGED ON (B)(6) 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED PJI AGAIN AND WAS REVISED WITH FEMUR AND ALL ROTATING HINGE COMPONENTS EXCHANGES ON (B)(6) 2021. THE PATIENT PRESENTS WITH SIGNS OF INFECTION AND AGAIN UNDERGOES L TKA REVISION ON (B)(6) 2022, WITH ALL ROTATING COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 16944034 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD AN INDEX LEFT TKA OUTSIDE OF CORS SCOPE. THE PATIENT DEVELOPED PJI (PERIPROSTHETIC JOINT INFECTION) IN THE LEFT KNEE AND UNDERWENT REVISION WITH A GMRS SYSTEM FOR PJI WITH ALL COMPONENTS EXCHANGED ON SEPTEMBER 21ST, 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED AGAIN PJI AND WAS REVISED WITH FEMUR AND ALL ROTATING HINGE COMPONENTS EXCHANGED ON (B)(6), 2021.

  Patient problems: Unspecified Infection

  MAUDE report 15307914 ↗
• InjuryMar 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. SURGEON PERFORMED AN IRRIGATION AND DEBRIDEMENT AND EXCHANGED POLY AND ASSOCIATED COMPONENTS (INSERT, BUMPER, BUSHINGS, ROTATING COMPONENT, AXLE, TIBIAL SLEEVE) FOR COMPONENTS OF THE SAME CATALOG NUMBERS.

  Patient problems: Unspecified Infection

  MAUDE report 13868712 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PATIENT FELL AND OPENED PART OF THE INCISION. DR. CHANGED OUT COMPONENTS JUST AS A PRECAUTION. NO DAMAGE WAS DONE TO THE IMPLANTS." LEFT KNEE. AN MRH TIBIAL ROTATING COMPONENT, MRH TIBIAL INSERT, MRH BUSHINGS, MRH KNEE BUMPER INSERT, AND MODULAR ROTATING HINGE WERE SWAPPED FOR THE SAME COMPONENTS.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 12907181 ↗
• InjuryMay 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  POSTOPERATIVE DIAGNOSIS: THE PATIENT HAD HISTORY OF RIGHT TOTAL KNEE REPLACEMENT. PATIENT UNDERWENT A RIGHT REVISION TOTAL KNEE ARTHROPLASTY AS SECOND STAGE REIMPLANTATION FOR A PERIPROSTHETIC JOINT INFECTION (B)(6) 2018. PATIENT UNDERWENT RIGHT REVISION KNEE ARTHROPLASTY, IRRIGATION AND DEBRIDEMENT AND COMPLEX WOUND CLOSURE WITH ALL MOBILE ROTATING COMPONENTS EXCHANGED (B)(6) 2018.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8570184 ↗