GMRS 6495-5-012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327033502), received between Jun 10, 2024 and Jun 21, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K022403, K023087, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS PI IS FOR IMPLANT DISSOCIATION AFTER REVISION. IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS ORIGINALLY REVISED 12 DAYS AFTER IMPLANTATION DUE TO DISSOCIATION OF THE STEM FROM THE STEM EXTENDER. INTRA-OPERATIVELY, IT WAS CONFIRMED THAT NO IMPLANTS BROKE, THEY SIMPLY SEPARATED. SURGEON REDUCED THE PATIENT AND RE-IMPACTED THE IMPLANTS (NOTHING WAS REMOVED). REP CONFIRMED THERE WAS NOTHING UNUSUAL ABOUT THE TECHNIQUE FOR THE ORIGINAL IMPLANTATION. SURGEON HAS EXPERIENCE WITH THE IMPLANT SYSTEM OVER HUNDREDS OF CASES. 9 DAYS AFTER REVISION, SURGEON NOTIFIED REP THAT THE IMPLANTS DISSOCIATED AGAIN. AT THE TIME OF REPORT, SURGEON'S PLAN FOR THE PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19583158 ↗
• InjuryJun 10, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED 12 DAYS AFTER IMPLANTATION DUE TO DISSOCIATION OF THE STEM FROM THE STEM EXTENDER. INTRA-OPERATIVELY, IT WAS CONFIRMED THAT NO IMPLANTS BROKE, THEY SIMPLY SEPARATED. SURGEON REDUCED THE PATIENT AND RE-IMPACTED THE IMPLANTS (NOTHING WAS REMOVED). REP CONFIRMED THERE WAS NOTHING UNUSUAL ABOUT THE TECHNIQUE FOR THE ORIGINAL IMPLANTATION. SURGEON HAS EXPERIENCE WITH THE IMPLANT SYSTEM OVER HUNDREDS OF CASES.

  Patient problems: Insufficient Information

  MAUDE report 19496938 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K022403, K023087, 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