GMRS 6495-2-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 07613327048780), received between Nov 5, 2018 and May 19, 2026 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 reports).

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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: REVISION OF GMRS DISTAL FEMORAL REPLACEMENT DUE TO FRACTURE OF THE PROXIMAL FEMUR.

  Patient problems: Insufficient Information

  MAUDE report 25225374 ↗
• InjuryMay 11, 2026Corroded

  THE FOLLOWING INFORMATION WAS PROVIDED: IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO PATIENT COMPLAINT OF PAIN AND SWELLING. INTRA-OPERATIVELY, SURGEON REPORTED CORROSION BETWEEN THE GMRS FEMORAL COMPONENT AND THE STEM. THE FEMORAL COMPONENT AND AXLE WERE REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. Q.

  Patient problems: Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 25134399 ↗
• InjuryNov 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF KNEE WITH GMRS DISTAL FEMUR INSITU DUE TO SURGEON REPORT OF SYNOVITIS. SEVERAL COMPONENTS WERE REPLACED, BUT NO REPORT OF COMPONENT INVOLVEMENT.

  Patient problems: Synovitis

  MAUDE report 23454881 ↗
• InjuryAug 5, 2025Mechanical Problem; Mechanical Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: MECHANICAL FAILURE, PAIN. ALL COMPONENTS REMOVED. RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 22713669 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: PERIPROSTHETIC FEMORAL FRACTURE. FEMORAL COMPONENT REVISED. RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 22680680 ↗
• InjuryOct 11, 2023Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO LOOSENING AND SUBSIDENCE OF THE FEMORAL COMPONENT AND LOOSENING OF THE TIBIAL BASEPLATE. THE PATIENT'S DISTAL FEMORAL REPLACEMENT CONSTRUCT WAS REMOVED AND A COMPETITOR COMPRESS WAS IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 17910725 ↗
• InjuryJul 20, 2023Unstable; Unstable

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED. AS REPORTED: "PATIENT REVISED DUE TO PATELLAR INSTABILITY. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY." A DISTAL FEMORAL COMPONENT, ROTATING HINGE, AXLE, BUSHINGS, BUMPER INSERT, TIBIAL INSERT, BASEPLATE, TIBIAL SLEEVE, AND STEM WERE REVISED (REP CONFIRMED PATELLAR COMPONENT WAS RETAINED).

  Patient problems: Joint Laxity

  MAUDE report 17359498 ↗
• InjuryFeb 2, 2023Loss of Osseointegration; Loss of Osseointegration

  A PATIENT SPECIFIC IMPLANT REQUEST WAS RECEIVED FOR THE PATIENT'S RIGHT DISTAL FEMUR. NOTED ON THE FORM: "S/P RESECTION AND RECONSTRUCTION RIGHT DISTAL FEMUR WITH STRYKER GMRS AND NOW SECOND EPISODE OF ASEPTIC LOOSENING RETAINING 8MM LARGE ALL0POLY TIBIA." PROPOSED DATE OF SURGERY IS ON (B)(6) 2023.

  Patient problems: Inadequate Osseointegration

  MAUDE report 16282762 ↗
• InjuryNov 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO DECREASED ROM. AN ARTHROFIBROSIS EXCISION (SOFT TISSUE REMOVAL) WAS PERFORMED AND THE DISTAL FEMORAL COMPONENT WAS DOWNSIZED FROM STANDARD TO SMALL.

  Patient problems: Loss of Range of Motion

  MAUDE report 15842760 ↗
• InjuryNov 7, 2022Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT KNEE WAS REVISED. A GMRS/ MRH CONSTRUCT WAS IMPLANTED. UPDATE (B)(6) 2022: SPOKE TO REP. REASON FOR REVISION WAS MIGRATION OF THE STEM AND SUSPECTED LOOSENING OF THE DISTAL FEMORAL COMPONENT (LOOSENING CONFIRMED INTRA-OPERATIVELY). THE STEM AND DISTAL FEMUR WERE REVISED TO THE SAME CATALOG NUMBERS. OTHER INTERNAL COMPONENTS (INSERTS, BUSHES, AXLE, ETC) WERE ALSO REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST ANY OF THE OTHER REVISED COMPONENTS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15742473 ↗
• InjuryJun 25, 2021Loss of Osseointegration; Migration; Loss of Osseointegration; Migration

  ASEPTIC MOBILIZATION DURING A SECONDARY IMPLANT FOR KNEE PROSTHESIS REVISION.

  Patient problems: Inadequate Osseointegration; Insufficient Information

  MAUDE report 12065105 ↗
• InjuryDec 18, 2020Adverse 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 STIFFNESS. ALL IMPLANTS EXCEPT THE MRH TIBIAL BASEPLATE AND STEM EXTENDER WERE REVISED; HOWEVER THERE ARE NO ALLEGATIONS AGAINST THE IMPLANTS AND STIFFNESS WAS ATTRIBUTED ONLY TO SCAR TISSUE. REP PROVIDED AN EXPLANT PICTURE AND PRIMARY AND REVISION USAGE SHEETS. THE REP CONFIRMED THAT NO FURTHER INFORMATION WOULD BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Scar Tissue

  MAUDE report 11035152 ↗
• InjuryJan 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A NOTE AT THE BOTTOM OF THE SHEET REPORTS "REVISED FOR INSTABILITY AND POSSIBLE INFECTION". AN MRH KNEE CONSTRUCT WAS REVISED TO AN MRH/ GMRS KNEE CONSTRUCT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9628571 ↗
• InjuryDec 13, 2019Loss of Osseointegration; Loss of Osseointegration

  PATIENT HAD A DISTAL FEMORAL REPLACEMENT 14 MONTHS AGO AND FEMORAL COMPONENTS BECAME LOOSE. PATIENT HAD PAIN. PATIENT REQUIRED REVISION SURGERY. UPDATE 21/NOVEMBER/2019 (B)(6): SPOKE TO REP. RIGHT FEMUR. THE FEMORAL COMPONENT, EXTENSION PIECE, FLUTED STEM, BUSHINGS AND BUMPER INSERT WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST ANY DEVICES BESIDES THE LOOSE FEMORAL COMPONENT. REP PROVIDED THE PRIMARY IMPLANT REPORT AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Inadequate Osseointegration; Injury

  MAUDE report 9466841 ↗
• MalfunctionNov 5, 2018Packaging Problem; Packaging Problem

  THIS PI IS FOR THE INTRA-OPERATIVE EVENT ON (B)(6) 2018. IT WAS REPORTED THAT DURING REVISION OF PATIENT'S RIGHT KNEE, THE OUTER RIM OF THE OUTER BLISTER WAS ATTACHED TO THE TYVEK AS THE IMPLANT WAS OPENED. A CORNER OF THE INNER BLISTER WAS NOT ADHERED TO THE TRAY. DUE TO STERILITY CONCERNS, THE SURGEON ELECTED TO RE-IMPLANT THE EXPLANTED COMPONENTS AS NO BETTER ALTERNATIVES WERE AT HAND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8039223 ↗

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