GMRS 6495-2-030Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327049824), received between May 17, 2019 and Apr 20, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Corroded” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K023087, K222056, K233261, K241716); they may or may not involve this specific model.

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.

• InjuryApr 20, 2026Unstable; Malposition of Device

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE IMPENDING 2025 REVISION. AS PER PSS IMPLANT REQUEST CASE: CONVERSION OF STRYKER LEFT GMRS DISTAL FEMUR & PROXIMAL TIBIA TO A FIXED HINGE. 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 UTILISED ON FEMUR OR TIBIA, WILL CONFIRM ONCE IMAGING IS RECEIVED FROM SURGEON. UPDATE: THIS REVISION WAS BOOKED FOR PATELLA STABILIZATION. THE PATIENT HAS A CHRONICALLY SUBLUXING PATELLA DUE TO THE ROTATING HINGE COMPONENT OF THE PROSDASTHESIS. A PROSTHESIS WHICH LIMITS THE ROTATION RATHER THAN ELIMINATING IT WOULD BE ACCEPTABLE TOO. MI SESTIMATE THE PATELLA DISLOCATES WHEN THE TIBIA EXTERNALLY ROTATES¿ UPDATE 25/3/2026: COMPLETION OF CUSTOM PROXIMAL TIBIA REPLACEMENT AND REVISION. SUCCESSFUL COMPLETION OF SURGERY. SURGEON MODIFIED MRH AXLE 64812120 WITH CEMEN

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 24933887 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: AS PER PSS IMPLANT REQUEST: LEFT GMRS WITH MULTIPLE QUAD RUPTURES WITH DIFFICULTY WITH CASTS AND BRACES AFTER REPAIR. REVISION SURGERY. ANTICIPATE CONVERTING BACK TO ROTATING HINGE IN ABOUT 3 MONTHS.

  Patient problems: Insufficient Information

  MAUDE report 23346350 ↗
• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING OF FEMORAL COMPONENT. FEMORAL COMPONENT REVISED. LEFT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22683198 ↗
• InjuryJul 22, 2024Corroded; Corroded

  IT WAS REPORTED THE PATIENT'S LEFT KNEE WAS REVISED DUE TO COMPLAINT OF PAIN. ORIGINAL PLAN WAS TO RESURFACE THE PATIENT'S NATIVE PATELLA. THOUGH PATIENT WAS NEGATIVE FOR INFECTION, SURGEON DECIDED TO REVISE THE DISTAL FEMORAL COMPONENT, STEM, AND EXTENDER OUT OF AN ABUNDANCE OF CAUTION. WHEN THE DEVICES WERE DISSOCIATED, CORROSION WAS NOTED AT THE JUNCTION OF THE DISTAL FEMUR AND EXTENSION, AND THE JUNCTION OF THE EXTENSION AND STEM. REP CAN PROVIDE PICTURES AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 19801555 ↗
• InjuryJun 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT DISTAL FEMUR REPLACEMENT WAS REVISED DUE TO INFECTION. ALL DEVICES EXCEPT THE TIBIAL BASEPLATE AND A STEM WERE REVISED. ASIDE FROM ATTACHED PRIMARY AND REVISION, USAGE SHEETS, REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11918461 ↗
• InjuryFeb 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT DISTAL FEMUR WAS REVISED DUE TO CONTRACTION OF SOFT TISSUES. THE DISTAL FEMUR, ROTATING COMPONENT, AND POLY COMPONENTS WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 11308413 ↗
• InjuryMay 17, 2019Migration; Migration

  THIS PI IS FOR SECOND DEBRIDEMENT. ON (B)(6) 2018, THE GMRS IMPLANT WAS INSERTED AFTER BEING DIAGNOSED WITH OSTEO SARCOMA AND THE TUMOR REMOVED. 4 MONTHS LATER, FOUND THAT THERE WAS AN INFECTION ON THE IMPLANT. THE IMPLANT WAS NOT REMOVED BUT DEBRIDEMENT WAS DONE. SINCE THE SURROUNDING MUSCLE AND TISSUES WERE HEALTHY NO FURTHER PROCEDURE WAS REQUIRED. AGAIN IN (B)(6) 2019 INFECTION OCCURRED AND A SECOND DEBRIDEMENT PROCEDURE WAS DONE. ANTIBIOTIC BEADS WERE USED. DURING THE SECOND TIME DEBRIDEMENT IT WAS FOUND THAT THE IMPLANT HAS MOVED FROM ITS IMPLANTED LOCATION AND IT IS CAUSING SEVERE UNBEARABLE PAIN. UPDATE 5/17/2019: PER COMMUNICATION WITH COMPANY REP, SUBJECT DEVICE WAS IDENTIFIED AS THE FEMORAL COMPONENT.

  Patient problems: Injury; Pain; Unspecified Infection

  MAUDE report 8621310 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023087, K222056, K233261, K241716. One submission often covers many models, so check the product and lot details in each record.

• Z-2732-2024 · Aug 5, 2024 · Open, Classified
  Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
• Z-2624-2010 · May 5, 2005 · Terminated
  GMRS Extension Piece, 60 mm; Sterile Stryker Howmedica Osteonics; Howmedica Internation S. de. R.L. Limerick, Ireland. The Global Modular Replacement System is intended to be used