MRH 6481-3-210Recalls & reported problems

Summary

The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI 07613327043785), received between Jul 12, 2018 and Aug 27, 2026 — classified as 25 injuries.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.

• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  Revision/exploration of distal femur GMRS R due to pain. Revised distal femur and articulating components- patella added. No issue with devices reported. Notification only.

  Patient problems: Pain

  MAUDE report 50476269 ↗
• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50422111 ↗
• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF PATIENT S.W. DISTAL FEMUR GMRS ORIGINALLY PUT IN ON (B)(6) 2025 (ORIGINAL CASE OA 11897482) DUE TO INFECTION AT (B)(6) HOSPITAL ON (B)(6) 2026 TO T2 NAIL CEMENT SPACER (STAGE 1).

  Patient problems: Unspecified Infection

  MAUDE report 25511432 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF LEFT MRH, 2 STAGE, DUE TO LIKELY INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 24055187 ↗
• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF BEARINGS COMPONENT OF MRH DUE TO INFECTION. DAIR PROCEDURE. DAIR DUE TO INFECTION ONLY.

  Patient problems: Unspecified Infection

  MAUDE report 23744422 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT KNEE. PATIENT REVISED DUE TO POSSIBLE INFECTION. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Unspecified Infection

  MAUDE report 23450883 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE 2023 REVISION. AS PER PSS IMPLANT REQUEST: CONVERSION OF STRYKER LEFT GMRS DISTAL FEMUR & PROXIMAL TIBIA TO A FIXED HINGE. PLEASE SEE USAGE STICKERS GIVEN FOR INITIAL (B)(6) 2023 AND REVISION CASE (B)(6) 2023 LEFT PROXIMAL TIBIA AND DISTAL FEMORAL GMRS IN-SITU, REQUIRES CONVERSION TO FIXED HINGE. LEAVING AS MUCH OF CURRENT IMPLANT IN-SITU. INITIAL IMPLANTATION OF PROXIMAL TIBIA GMRS AND DISTAL FEMORAL GMRS COMPLETED ON (B)(6) 2023 WITH 10MM TIBIAL INSERT, REVISED ON (B)(6) 2023 TO 16MM TIBIAL INSERT. A 30MM EXTENSION PIECE WAS USED, UNSURE ON WHETHER THIS WAS UTILIZED ON FEMUR OR TIBIA, WILL CONFIRM ONCE IMAGING IS RECEIVED FROM SURGEON.

  Patient problems: Insufficient Information; Joint Dislocation

  MAUDE report 23346347 ↗
• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS FOR THE REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2023. IN PROVIDING INFORMATION FOR A REVISION OF THE PATIENT'S LEFT KNEE ON (B)(6) 2024, REP PROVIDED USAGE FOR A PRIOR PROCEDURE ON (B)(6) 2023. PER REPORTED PATIENT HISTORY, PATIENT ALSO HAD PRIOR REVISION ON (B)(6) 2023. PER SALES REP: PATIENT WAS REVISED DUE TO ONGOING INFECTION (REPORTED AS MRSA) AS WELL AS OTHER COMORBIDITIES. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Bacterial Infection

  MAUDE report 19144385 ↗
• InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH WOUND DEHISCENCE OF HER SURGICAL WOUND FOLLOWING PREVIOUS REVISION ON (B)(6) 2024. DOCTOR OPTED TO PERFORM AN EXTENSIVE I&D AND SWAP-OUT ALL THE MODULAR COMPONENTS THAT JOIN THE FEMUR AND TIBIA. FEMUR AND TIBIA COMPONENTS LEFT IN-SITU, NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Wound Dehiscence

  MAUDE report 18873029 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION LTKA FOR INFECTION. PATIENT HAS MRSA. I&D WITH CHANGING THE MOVEABLE PARTS.

  Patient problems: Bacterial Infection

  MAUDE report 18863831 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE I&D PERFORMED 'A WHILE BACK.' REP CONFIRMED THAT NO IMPLANTS WERE REVISED AT THAT TIME. AS REPORTED: REVISION PERFORMED TODAY. PT. PRESENTED WITH A DRAINING SURGICAL WOUND OF THE LEFT KNEE, FOLLOWING AN I&D AND PLACEMENT OF RESORBABLE/ABSORBABLE ANTIBIOTIC BEADS "A WHILE BACK". DR. OPTED TO SWAP OUT THE COMPONENTS LISTED ON THE SURGERY SHEET (PIECE-FOR-PIECE). PT. RECEIVED A LEFT PROXIMAL TIBIA REPLACEMENT "ABOUT 10 YEARS AGO", NO FURTHER INFO AVAILABLE. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES.

  Patient problems: Wound Infection

  MAUDE report 18772510 ↗
• InjuryFeb 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE REVISION ON (B)(6) 2024 (TODAY). AS REPORTED: REVISION PERFORMED TODAY. PT. PRESENTED WITH A DRAINING SURGICAL WOUND OF THE LEFT KNEE, FOLLOWING AN I&D AND PLACEMENT OF RESORBABLE/ABSORBABLE ANTIBIOTIC BEADS "A WHILE BACK". DR. OPTED TO SWAP OUT THE COMPONENTS LISTED ON THE SURGERY SHEET (PIECE-FOR-PIECE). PT. RECEIVED A LEFT PROXIMAL TIBIA REPLACEMENT "ABOUT 10 YEARS AGO", NO FURTHER INFO AVAILABLE. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES.

  Patient problems: Wound Infection

  MAUDE report 18772499 ↗
• InjuryDec 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO SUSPECTED INFECTION. AN INSERT, ROTATING COMPONENT, AXLE, AND BUSHINGS/ SLEEVE/ BUMPER WERE REVISED FOR IMPLANTS OF THE SAME CATALOG NUMBER. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18299620 ↗
• InjuryNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION LEFT TKA. REPLACED ALL THE MOVEABLE PARTS DUE TO FLEXION CONTRACTION. DID A POSTERIOR CAPSULE RELEASE." REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Loss of Range of Motion

  MAUDE report 18189349 ↗
• InjuryJul 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE SALES REP THAT THE PATIENT INFECTED WITH ECOLI AND REVISION SURGERY COMPLETED ON (B)(6) 2023. THIS IS THE FIRST REVISION SURGERY WHEREAS PRIMARY SURGERY WAS ON (B)(6) 2021 IN WHICH THE EXPIRED IMPLANT WAS IMPLANTED ON PATIENT.

  Patient problems: Bacterial Infection

  MAUDE report 17332092 ↗
• InjuryMay 17, 2023Unstable; Unstable

  THE PATIENT HAD A PRIMARY TKA OUT OF CORS SCOPE. THE PATIENT PRESENTED PATELLAR CLUNK AND INSTABILITY DUE TO HYPEREXTENSION, SO HE UNDERWENT L TKA REVISION ON (B)(6) 2017, WITH AN MRH SYSTEM. THE PATIENT PROGRESSED WELL BUT DEVELOPED INSTABILITY AGAIN AND UNDERWENT L TKA REVISION ON (B)(6) 2022. ALL ROTATING COMPONENTS PLUS THE PATELLA WERE EXCHANGED.

  Patient problems: Joint Laxity

  MAUDE report 16945168 ↗
• InjuryMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE PLANNED REVISION OF THE PATIENT'S LEFT KNEE ARTHRODESIS ON (B)(6) 2023. NOTED ON THE PRESCRIPTION FORM: "55-YEAR-OLD MALE PATIENT, WITH INFECTED LEFT PROXIMAL TIBIA ENDOPROSTHESIS, HE RECEIVED, REMOVAL OF THE IMPLANT AND SERIAL DEBRIDEMENT, AND CURRENTLY ON IV ANTIBIOTICS. " "WE NEED TO RECONSTRUCT THE DEFECT WITH CUSTOM MADE KNEE ENDOPROSTHESIS IMPLANT, AS THE PATIENT HAS LIMITED KNEE FLEXION ALREADY, AND LOST A SIGNIFICANT PORTION OF HIS QUAD STRENGTH." UPDATE: "(B)(6) 2022 CHECK IN THE HOSPITAL WITH INFECTED WOUND, THEN DEVELOPED CHRONIC SINUS TRACT INFECTION". "PATIENT HAS A STIFF KNEE, AND DECREASED RANGE OF MOTION, HEAVY SMOKER (2 PACKS A DAY)".

  Patient problems: Unspecified Infection

  MAUDE report 16909302 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION LTKA I&D W/ ALL MOVEABLE PARTS AND DISTAL FEMUR. INFECTION, PATIENT FELL." REP CONFIRMED THERE WAS NO BONE FRACTURE ("JUST BLEW OUT THE INCISION") AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 16309961 ↗
• InjuryApr 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A STANMORE PATIENT SPECIFIC PRESCRIPTION FORM WAS PROVIDED FOR THE PATIENT'S LEFT KNEE. NOTED ON THE FORM: "FOR INFECTED PROXIMAL TIBIA GMRS." PROPOSED DATE OF SURGERY IS (B)(6)2022.

  Patient problems: Unspecified Infection

  MAUDE report 14073776 ↗
• InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A DRAINING WOUND, OF A PREVIOUS SURGICAL INCISION. PERFORMED AN I&D OF THE WOUND." A TIBIAL SLEEVE, AXLE, ROTATING COMPONENT, TIBIAL INSERT, BUMPER INSERT, AND 2 FEMORAL BUSHINGS WERE REVISED.

  Patient problems: Fluid Discharge

  MAUDE report 13182215 ↗
• InjuryDec 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PROCEDURE: THE PATIENT HAD RIGHT KNEE REPLACEMENT OUTSIDE CORS SCOPE. PATIENT UNDERWENT REVISION OF REMOVAL OF ANTIBIOTIC SPACER AND RIGHT DISTAL FEMUR REPLACING ONCOLOGIC MEGAPROSTHESIS (B)(6) 2018. THE PATIENT UNDERWENT REVISION OF RIGHT LOWER EXTREMITY INFECTED MEGAPROSTHESIS (B)(6) 2019. PATIENT GOT REINFECTION OF RIGHT TKA AND UNDERWENT RESECTION OF ALL COMPONENTS ON (B)(6) 2020. PATIENT THEN HAD REIMPLANTATION ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 11059971 ↗
• InjuryOct 25, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT PATIENT'S RIGHT DISTAL FEMUR WAS REVISED DUE TO WEAR AND DEBRIS FROM THE INSERT AND SLEEVE. SURGEON HAS REQUESTED THAT AN ELEMENTAL ANALYSIS BE PERFORMED ON THE DEVICES, WHICH WILL BE RETURNED.

  Patient problems: Injury

  MAUDE report 9238824 ↗
• InjuryOct 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PROCEDURE: THE PATIENT HAD RIGHT KNEE REPLACEMENT OUTSIDE CORS SCOPE. PATIENT UNDERWENT REVISION OF REMOVAL OF ANTIBIOTIC SPACER AND RIGHT DISTAL FEMUR REPLACING ONCOLOGIC MEGAPROSTHESIS (B)(6) 2018. THE PATIENT UNDERWENT REVISION OF RIGHT LOWER EXTREMITY INFECTED MEGAPROSTHESIS (B)(6) 2019.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9211149 ↗
• InjuryOct 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: INDEX AND REVISION SURGEON: "PROCEDURE: PATIENT UNDERWENT INDEX TKA OUTSIDE OF CORS SCOPE. THE PATIENT UNDERWENT REVISION OF BOTH FEMORAL AND TIBIAL COMPONENTS SECONDARY TO PJI ON (B)(6) 2017. PATIENT UNDERWENT A SECOND REVISION OF LEFT KNEE DUE TO INFECTION ON (B)(6) 2018."

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7969793 ↗
• InjuryJul 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT FEMUR WAS REVISED DUE TO POSSIBLE INFECTION. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. UPDATE 22/JUN/2018: ALL REPORTED DEVICES WERE EXPLANTED.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7682856 ↗