GMRS 6495-3-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327048810), received between May 29, 2018 and Jan 31, 2024 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S KNEE WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A RUPTURED PATELLAR TENDON, REQUIRING A REPAIR OF THEIR EXTENSOR MECHANISM. DR. PERFORMED A REPAIR OF THE SOFT TISSUE AND SWAPPED OUT THE PLASTIC COMPONENTS. ALL METAL COMPONENTS WERE RETAINED, NO COMPLAINTS WERE FILED AGAINST THE COMPONENTS THEMSELVES."

  Patient problems: Rupture

  MAUDE report 18615584 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR REVISION DUE TO INFECTION ON (B)(6) 2017. A PATIENT SPECIFIC IMPLANT REQUEST FORM WAS RECEIVED FOR THE PATIENT'S DISTAL FEMUR/ PROXIMAL TIBIA REPLACEMENTS INDICATE A PRIOR REVISION ON (B)(6) 2017. AS NOTED ON THE FORM: "HE HAD A WASHOUT (B)(6) 2017 WITH JUST CHANGE OUT OF THE BUMPER, BUSHINGS, TIBIAL SLEEVE AND PTR AND INFECTION FREE SINCE THEN."

  Patient problems: Unspecified Infection

  MAUDE report 15984813 ↗
• InjuryAug 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD LEFT TKA OUT OF CORS SCOPE (OFF-LABEL) ON (B)(6) 2016. THE PATIENT DEVELOPED PJI AND WAS REVISED (ALL COMPONENTS) ON (B)(6) 2017 (IS THEN INCLUDED IN CORS) THE PATIENT RECEIVED A GMRS SYSTEM. THE PATIENT DEVELOPED AGAIN PJI AND IS REVISED ON (B)(6) 2021. ONLY THE ROTATING HINGE COMPONENTS WERE EXCHANGED.

  Patient problems: Unspecified Infection

  MAUDE report 15307913 ↗
• InjuryMay 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S LEFT KNEE WAS REVISED DUE TO INFECTION (UNKNOWN IF CLINICALLY CONFIRMED OR IDENTIFIED).

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7548410 ↗

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