GMRS 6495-3-102Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327048865), received between Nov 1, 2018 and Mar 17, 2026 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K023087, K222056, K233261); 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMar 17, 2026Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: THIS PI IS FOR THE 2021 REVISION: AS PER PSS CASE: LOOSENING RIGHT DISTAL TIBIA. 1ST SURGERY GMRS PROXIMAL TIBIA WITH CEMENTED STEM (B)(6) 2019. 2ND SURGERY LONGER EXTENSION WITH 17MM CEMENTLESS STEM (B)(6) 2021. REQUESTING CUSTOM MADE STEM. CEMENTLESS 7CM IN LENGTH. UPDATE: THIS PI IS FOR THE 2021 REVISION: AS PER PSS CASE: LOOSENING RIGHT PROXIMAL TIBIA STEM. 1ST SURGERY GMRS PROXIMAL TIBIA AND DISTAL FEMUR WITH CEMENTED STEMS (B)(6) 2019. 2ND SURGERY REVISION OF LOOSE CEMENTED FEMUR STEM WITH CEMENTLESS STEM (B)(6) 2021. REQUESTING CUSTOM MADE STEM. SHOT TIBIAL STEM CEMENTLESS 7CM IN LENGTH.

  Patient problems: Inadequate Osseointegration

  MAUDE report 24616798 ↗
• InjurySep 1, 2022Loss of Osseointegration; Loss of Osseointegration

  A PATIENT SPECIFIC PRESCRIPTION FORM HAS BEEN RECEIVED "PROXIMAL TIBIAL REPLACEMENT - LOOSENING WITH SIGNIFICANT TIBIAL STRESS REACTION - FOR GIANT CELL TUMOUR" UPDATE (B)(6) 2022 : AS REPORTED VIA UPDATED IMPLANT REQUEST FORM: "REVISION OF A GMRS PROXIMAL TIBIA. THIS WILL BE THE 3RD REVISION. NEED A DISTAL END PIECE THAT WILL CONNECT TO THE MRH SECTION OF THE FEMUR."

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 15342534 ↗
• MalfunctionFeb 25, 2019Packaging Problem; Packaging Problem

  STANDARD PROXIMAL TIBIA (GMRS) 6495-3-102 WAS OPENED IN THE OPERATING ROOM. THE NON-STERILE OUTER PACKAGING WAS REMOVED FROM THE IMPLANT BOX. WHEN PEELING OPEN THE OUTER PACKAGE TO EXPOSE THE INNER STERILE PACKAGE, PART OF THE OUTER PLASTIC PACKAGE WAS TORN AWAY WITH THE PEEL AWAY PAPER TOP. THE INNER STERILE PACKAGE APPEARED TO BE UNDAMAGED. UPON OPENING THE INNER STERILE PACKAGE, DEBRIS WAS FOUND IN AROUND THE PROXIMAL TIBIAL IMPLANT. THE DEBRIS APPEARED TO BE LITTLE WHITE FIBERS OR SMALL PARTICLES OF THE PAPER SEAL FROM THE INNER STERILE PACKAGE. QUESTIONS AROSE REGARDING THE INTEGRITY OF THE OUTER PACKAGING AND THE SUBSEQUENT STERILITY OF THE IMPLANT WITHIN THE INNER PACKAGE. SURGEON DECIDED NOT TO IMPLANT THE STANDARD PROXIMAL TIBIA. THE SMALL PROXIMAL GMRS SEGMENT WAS SUBSTITUTED OUT OF NECESSITY. TOURNIQUET WAS INFLATED FOR 120 MINUTES, DEFLATED FOR 20, THEN REINFLATED FOR 30 ADDITIONAL MINUTES, TOTAL TOURNIQUET TIME 150 MINUTES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8367785 ↗
• InjuryNov 1, 2018Device Unsafe to Use in Environment; Device Unsafe to Use in Environment

  THE DOCTOR REPORTED TO SALES REP AN INTERACTION OF GMRS PROSTHESIS WITH THE ELECTROMAGNETIC FIELD DURING MRI SCANNING OF THE PATIENT.

  Patient problems: No Information

  MAUDE report 8027617 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023087, K222056, K233261. 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