GMRS 6495-3-016Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327048827), received between Dec 23, 2019 and Jul 3, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 3, 2023Adverse 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 INFECTION. A GMRS DISTAL FEMUR / KNEE WAS REMOVED AND A TOTAL FEMUR (HEMI ACETABULAR IMPLANTS, GMRS/ MRH KNEE COMPONENTS) WAS IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 17244702 ↗
• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PT. PRESENTED WITH DEHISCENCE OF THEIR SURGICAL WOUND DUE TO A FALL, FOLLOWING A PROXIMAL-TIBIA REPLACEMENT ON 9/14. DR. PERFORMED AN EXTENSIVE-I&D AND EXCHANGE OF THE POLY-COMPONENTS OF THE CONSTRUCT. NO COMPLAINTS AGAINST THE COMPONENTS THEMSELVES.

  Patient problems: Fall; Wound Dehiscence

  MAUDE report 15623473 ↗
• InjuryDec 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "NO OTHER DOCUMENTS TO BE PROVIDED BY PHYSICIAN OR HOSPITAL. PATIENT'S RIGHT KNEE. DON'T HAVE A RECORD OF PREVIOUS SURGERY DATE. NO TRAUMA CASES TO PATIENT. HOSPITAL NOT RELEASING IMPLANTS TO BE RETURNED." REP PROVIDED A REVISION USAGE SHEET WITH EXPLANTS HAND-WRITTEN, AND A PRE-REVISION X-RAY. UPDATE: "PATIENT COMPLAINED OF INABILITY TO FULLY STRAIGHT LEG (LACKED FULL ROM OF KNEE)".

  Patient problems: Injury; Loss of Range of Motion

  MAUDE report 9513170 ↗

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