MRH 6481-3-213Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07613327043792), received between Mar 21, 2017 and Aug 25, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  As reported: "Patient revised due to chronic infection. No other information available due to hospital policy." Surgery performed 1 day after date of awareness. All components except a baseplate and stem(s) were removed. Left DFR.Revision, infection.

  Patient problems: Unspecified Infection

  MAUDE report 50430781 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: INFECTION - REMOVAL OF ARTICULATING COMPONENTS AND POLY. INFECTION PROTOCOL DAIR.

  Patient problems: Unspecified Infection

  MAUDE report 23836418 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED A REVISION OF RIGHT KNEE DUE TO INFECTION. PATIENT WOULD LIKE TO KNOW IF IMPLANTS ARE SUBJECT TO A RECALL.

  Patient problems: Unspecified Infection

  MAUDE report 18872815 ↗
• InjuryJun 14, 2023Adverse 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. AS REPORTED: "PT. PRESENTED WITH CLINICAL SIGNS OF INFECTION. DR. PERFORMED AN ¿EXTENSIVE I&D¿ AND SWAP OF SOME GMRS/MRH COMPONENTS. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO AVAILABLE." BUSHINGS, INSERTS, SLEEVE AND AXLE (IMPLANTED (B)(6) 2022), AND AN EXTENSION PIECE (IMPLANT DATE UNKNOWN) WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 17122886 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY RIGHT TKA OUTSIDE CORS SCOPE. ON (B)(6) 2022 PATIENT DEVELOPED PJI REQUIRING REVISION OF ALL COMPONENTS. PATIENT PRESENTED AGAIN WITH PAIN AND SIGNS OF PJI. WAS REVISED ON (B)(6) 2022. ALL COMPONENTS EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 15974407 ↗
• 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 (B)(6) 2021 (THEN INCLUDED INTO CORS). THE PATIENT DEVELOPED AGAIN PJI AND WAS REVISED ONLY FOR ALL ROTATING HINGE COMPONENTS EXCHANGED ON (B)(6) 2021.

  Patient problems: Unspecified Infection

  MAUDE report 15307915 ↗
• InjuryMay 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE FIRST OF A 2-STAGE REVISION DUE TO INFECTION BETWEEN 2017 AND 2021. ON (B)(6) 2017, PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION. AT AN UNKNOWN DATE AFTER THAT AND AT AN UNKNOWN FACILITY, THE PATIENT HAD A FIRST STAGE REVISION OF ALL COMPONENTS AND THE PLACEMENT OF A SPACER. ON (B)(6) 2021, THE SECOND STAGE REVISION TOOK PLACE WITH REMOVAL OF THE SPACER AND PLACEMENT OF STRYKER IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 14365562 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT RIGHT INDEX TKA OUTSIDE OF CORS SCOPE. PATIENT PRESENTS WITH PAIN AND DISRUPTION EXTENSOR MECHANISM. SHE IS REVISED FOR PJI ON (B)(6) 2019, ALL COMPONENTS WERE EXCHANGED. PATIENT PRESENTS AGAIN. SHE IS STUDIED FOR INFECTION. PATIENT IS REVISED ON (B)(6) 2021 FOR PJI. FEMORAL AND LINER, AND ROTATING COMPONENTS ARE EXCHANGED.

  MAUDE report 13765742 ↗
• InjuryMar 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS A (B)(6) FEMALE WHO PREVIOUSLY UNDERWENT RIGHT TOTAL KNEE REPLACEMENT - OUTSIDE CORS SCOPE. SHE UNDERWENT REVISION ON (B)(6) 2020 FOR PJI. PATIENT DEVELOPED PJI AND REQUIRED RESECTION AND SPACER PLACEMENT IN (B)(6) 2020. ALL COMPONENTS EXCHANGED. PATIENT UNDERWENT REIMPLANTATION ON (B)(6) 2020. THIS WAS REPORTED IN CORS. PATIENT PRESENTS WITH PJI AGAIN AND IS REVISED ON (B)(6) 2021. LINER AND ROTATING HINGE COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 13630269 ↗
• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT TKA OUTSIDE CORS SCOPE IN 2013, REQUIRED AN MUA ONE MONTH LATER. THE PATIENT DEVELOPED PJI WITH MSSA AND LATER WITH MRSA. HAS BEEN REVISED 5 TIMES OUT OF CORS SCOPE. IN (B)(6) 2017 THE PATIENT IS REIMPLANTED, NOW ENTERING CORS REGISTRY. PATIENT DEVELOPS AGAIN PJI AND INSTABILITY. PATIENT UNDERGOES RESECTION AND REVISION ON (B)(6) 2021. REPORTED IN CORS PER 7990KNEE COVERED IN A SEPARATE REPORT. PATIENT AGAIN PRESENTS WITH PJI, SO A RESECTION ARTHROPLASTY IS DONE ON (B)(6) 2021, WITH PLANS OF REIMPLANTATION LATER ON. PJI PERSIST, SO PATIENT IS TREATED FINALLY WITH AN RIGHT KNEE ARTHRODESIS ON (B)(6) 2022.

  Patient problems: Bacterial Infection

  MAUDE report 13598705 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S (B)(6) WAS REVISED. SURGEON REPORTED THE PATIENT HAD PULLED OUT HIS DRAINS POST-OPERATIVELY, WHICH LED TO THE DEVELOPMENT OF A (B)(6). THE INSERT, ROTATING COMPONENT, AXLE, BUSHINGS/ SLEEVE/ BUMPER, AND BUMPER INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 12819551 ↗
• InjuryJul 13, 2020Unstable; Unstable

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S LEFT KNEE WAS REVISED. A 13 MM MRH KNEE TIBIAL INSERT WAS REVISED TO A 10 MM MRH KNEE TIBIAL INSERT. SALES BRANCH PROVIDED PRIMARY AND REVISION USAGE SHEETS. UPDATE 07/JULY/2020 (B)(6) : SPOKE TO REP. PATIENT WAS REVISED DUE TO INSTABILITY. SURGEON REPORTED THAT THE ORIGINAL INSERT WAS TOO LARGE FOR THE PATIENT'S ANATOMY AND A SMALL SIZE WAS IMPLANTED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Joint Laxity

  MAUDE report 10263326 ↗
• InjuryApr 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT TREATED FOR DAIR.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9917677 ↗
• InjuryApr 1, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAS A HISTORY OF REVISIONS AT OTHER HOSPITALS OF WHICH ALL DETAILS I DO NOT HAVE ACCESS TO. WE ARE TOLD THAT THE FIRST TKR CASE WAS DONE 2014- PATIENT NOT SURE AND NO RECORDS. IT WAS REVISED (B)(6) 2019. GMRS DISTAL FEMUR/ MRH HINGE KNEE IMPLANTED. IN (B)(6) 2020 PATIENT TREATED FOR DIAR AGAIN. PATIENT PRESENTED ON THURSDAY EVENING (B)(6) 2020 AT HOSPITAL WITH A DISLOCATED PROSTHESIS. HE APPARENTLY WAS ONLY GETTING UP FROM A SEATED POSITION INTO THE STANDING POSITION WHEN IT DISLOCATED. DR. CONTACTED ME TO ASK FOR ASSISTANCE FOR THE CASE WHICH DR. WAS GOING TO ATTEMPT TO REDUCE AT AROUND MIDNIGHT. CASE ONLY STARTED AT 1:45AM AND CONCLUDED SUCCESSFULLY AT 2:15AM. DR DID SAY THAT PERHAPS A THICKER INSERT WOULD HAVE BEEN HANDY HOWEVER DUE TO THE LATE NATURE OF PATIENT PRESENTING AND URGENCY TO REDUCE- TIME WAS OF THE ESSENCE AND THAT LUXURY OF A POLY INSERT UPGRADE WAS NOT AN AVAILABLE OPTION. ISSUE WAS NOTED VIA X-RAY, ITS SHOWED CLEAR DISLOCATION- SEE PHOTO PRE OP AND X RAYS.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9913851 ↗
• InjuryFeb 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO TIBIAL PAIN. THE TIBIAL SIDE OF AN MRH KNEE CONSTRUCT WAS REVISED. REP PROVIDED THE REVISION USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 9772224 ↗
• InjuryJan 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "PRE-OP DIAGNOSIS: CELLULITIS OF RIGHT LOWER EXTREMITY. PROCEDURE: REMOVAL OF RIGHT TOTAL KNEE. REMOVED: ALL COMPONENTS. NO FURTHER INFORMATION AVAILABLE."

  Patient problems: Cellulitis; Injury

  MAUDE report 9592965 ↗
• InjuryNov 19, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO BEING TIGHT IN FLEXION. MRH BUMPER INSERT, ROTATING COMPONENT, AND ROTATING HINGE KNEE WERE EXCHANGED FOR THE SAME CATALOG NUMBERS. A 13MM TIBIAL INSERT WAS EXCHANGED FOR A 10MM TIBIAL INSERT.

  Patient problems: Ambulation or Postural Difficulties; Injury

  MAUDE report 8086413 ↗
• InjuryMar 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT 2 STAGE REVISION FOR INFECTION, WITH THE 2ND STAGE (RE-IMPLANTATION) COMPLETED (B)(6) 2016. PATIENT CONTINUED TO DRAIN, SO UNDERWENT EXTENSIVE IRRIGATION AND DEBRIDEMENT WITH POLY LINER AND TIBIAL COMPONENTS EXCHANGE ON (B)(6) 2016.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6420551 ↗