GMRS 6495-5-013Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327033496), received between Dec 13, 2019 and Dec 13, 2019 — classified as 1 injury.

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 (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD A DISTAL FEMORAL REPLACEMENT 14 MONTHS AGO AND FEMORAL COMPONENTS BECAME LOOSE. PATIENT HAD PAIN. PATIENT REQUIRED REVISION SURGERY. UPDATE 21/NOVEMBER/2019 (B)(6): SPOKE TO REP. RIGHT FEMUR. THE FEMORAL COMPONENT, EXTENSION PIECE, FLUTED STEM, BUSHINGS AND BUMPER INSERT WERE REVISED. THERE ARE NO ALLEGATIONS AGAINST ANY DEVICES BESIDES THE LOOSE FEMORAL COMPONENT. REP PROVIDED THE PRIMARY IMPLANT REPORT AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 9466884 ↗

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