GMRS 6495-5-011Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327033489), received between Mar 4, 2019 and Jun 3, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K022403, K023087, K031217, K222056, 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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 3, 2025Degraded; Fracture; Degraded; Fracture

  THIS PI IS FOR THE REVISION SURGERY PERFORMED ON (B)(6) 2008. PATIENT UNDERWENT RESECTION SURGERY IN 1989 PROXIMAL RIGHT TIBIA AND RECONSTRUCTION WITH HMRS MODULAR PROSTHESIS STRYKER FOR OSTEOSARCOMA. ON B)(6) 2008 SURGERY FOR REVISION OF THE TIBIAL PROSTHETIC COMPONENT DUE TO STEM RUPTURE. ON THAT OCCASION, THE PATIENT REPLACED THE HMRS TIBIAL STEM WITH GMRS STRYKER TIBIAL STEM (REF 6495-5-011, LOT 7W4074A) AND FITTED NEW TIBIAL PROSTHETIC BODY BY IMPLANTING HMRS 120MM TIBIAL PROSTHETIC COROPE, GMRS TIBIAL PROSTHETIC TENSE ADAPTER, AND GMRS 50MM TIBIAL SPACER (NO REPLACEMENT OF FEMORAL COMPONENT WHICH WAS INTACT). ON (B)(6) 2016 SURGERY REPLACEMENT OF RIGHT KNEE PROSTHETIC JOINT COMPONENTS DUE TO WEAR AND TEAR. ON (B)(6) 2016 SURGICAL CLEANUP FOR INFECTION PERI-PROSTHETIC TIBIAL, RETAINING TIBIAL STEM, AND IMPLANTATION OF ANTIBIOTIC CEMENT SPACER. ON (B)(6) 2017 ALSO EXPLANTATION OF FEMORAL PROSTHETIC COMPONENT AND FURTHER SURGICAL CLEANING WITH CEMENT SPACER RENEWAL. ON 24/MAR/2017 AND 19/MAY/2017 RENEWAL CEMENT SPACER. ON (B)(6) 2017 IMPLANTATION OF MODULAR TIBIA PROSTHESIS PROXIMAL DX IN KNEE ARTHRODESIS ALSO USING COMPONENT CUSTOM GMRS EXTENSION PIECE (REF C-M106-2-000; LOT TA

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 22131464 ↗
• InjuryOct 17, 2023Fracture; Fracture

  PATIENT HAD A REVISION FOR BROKEN GMRS 11 X 125 PRESS FIT FEMUR STEM ON RIGHT LEG. REVISION WAS PERFORMED DUE TO THE STEM BREAKING WHERE THE 11MM DIAMETER BEGINS TAPERING TO A WIDER DIAMETER. THE STEM, AN EXTENDER, FEMORAL COMPONENT, AND ROTATING COMPONENT WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 17948184 ↗
• InjuryMar 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT, FOR A PATIENT WHO WAS OPERATED SEVERAL TIMES BY THE SAME SURGEON, THE LAST SURGERY WAS THE SECOND FAILED ATTEMPT TO EXCHANGE THE GROWING PIECE OF HIS GMRS IMPLANT (HMRS/GMRS SPIGOT SEPARATOR). A LONGER GROWING PIECE IS NEEDED, GROWING PIECE THE PATIENT CURRENTLY HAS FAILED/LOST IT¿S ABILITY TO KEEP IT¿S FULL LENGTH. IT IS SUSPECTED THAT SEPARATION OF THE STEM/GROWING PIECE SPIGOT FAILED BECAUSE OF COLD FUSION. THE PATIENT ((B)(6) YEAR OLD BOY) HAS 6CM DIFFERENCE IN LEG LENGTH, THE ORIGINAL GROWING COMPONENT IS SET TO IT¿S MAXIMUM LENGTH BUT AS IT¿S COLLAPSED ONCE THE PATIENT¿S PARENTS LOST THEIR TRUST IN THE DEVICE. IT IS NOT CLEAR WHY/HOW THE DEVICE LOST IT¿S INTERNAL BLOCKAGE, BUT THE SURGEON FOUND IT COLLAPSED ( IN THE SHORTEST POSITION INSTEAD OF THE LAST SET ELONGATION ) IN THE OPERATION WHEN THEY WANTED TO DO THE LAST ADJUSTMENT ( THE LAST 5MM ) BEFORE CHANGING TO THE LONGER PIECE. AFTER THEY WENT THROUGH THE ELONGATION STEPS AGAIN - 2-3 SMALL SURGERIES - THEY REACHED FULL LENGTH AGAIN, THE DEVICE SHOWED NO SIGNS OF FAILURE/INSTABILITY.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 8386838 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022403, K023087, K031217, K222056, 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