GMRS 6495-2-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327048773), received between Aug 28, 2019 and Apr 11, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Degraded” (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

Recent adverse event reports

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

• InjuryApr 11, 2023Fracture; Fracture

  PATIENT HAD A RIGHT DISTAL FEMUR REPLACEMENT DUE TO BROKEN GMRS AXLE. AXLE, BUSHINGS, AND NEUTRAL BUMPER WERE REVISED.

  Patient problems: Insufficient Information

  MAUDE report 16719606 ↗
• InjuryOct 6, 2022Degraded; Material Erosion; Degraded; Material Erosion

  IT WAS REPORTED THAT THE SURGEON REVISED THE AXLE BUSHINGS AND BUMPER AS A RESULT OF EXCESSIVE WEAR.

  Patient problems: Ambulation or Postural Difficulties; Insufficient Information

  MAUDE report 15549936 ↗
• InjuryAug 28, 2019Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO WEAR OF THE POLY COMPONENT. POSSIBLE CAUSE OR CONTRIBUTOR FOR WEAR NOT REPORTED. PATIENT'S ACTIVITY LEVEL IS UNKNOWN. PATIENT WAS REVISED TO POLY COMPONENT OF THE SAME CATALOG NUMBER. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8939163 ↗

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