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GMRS 6495-6-030Recalls & reported problems

Howmedica Osteonics Corp. · Extension Piece · Class 2 · Implant

All models of GMRS (32)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327049152), received between Sep 15, 2020 and May 26, 2023 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 18, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Device Contamination with Chemical or Other Material1
  • Loss of Osseointegration1
  • Migration1

Patient problems

  • Inadequate Osseointegration1
  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1
  • Unequal Limb Length1

Recent adverse event reports

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

  • InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE PATIENT'S RIGHT GMRS DISTAL FEMUR WAS REVISED. SURGEON FELT THAT 5 WEEKS POST-IMPLANT, PATIENT'S RIGHT LEG WAS TOO LONG. A 30MM GMRS BODY WAS REMOVED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Unequal Limb Length

    MAUDE report 17012215 ↗
  • 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 12065102 ↗
  • MalfunctionSep 15, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    IT WAS REPORTED THAT, DURING A SURGERY, OUR SALES STAFF NOTICED A FOREIGN MATERIAL IN THE PACKAGE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10533766 ↗

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

Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices

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Sources and updates

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