GMRS 6495-6-080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327049220), received between Jan 26, 2018 and Jun 24, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Degraded; Loss of Osseointegration

  THE FOLLOWING INFORMATION WAS PROVIDED: THE PRIMARY PROCEDURE OF GMRS WAS DONE IN 2004. REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2026 DUE TO SUSPECTED TIBIAL LOOSENING. HOWEVER, WHEN DR KC WONG OPEN THE JOINT CAPSULE, MASSIVE AND EXTENSIVE METALLOSIS WAS SEEN AROUND THE PROSTHESIS. WHEN WE TRY TO IMPACT A NEW 80MM EXTENSION PIECE, WE FOUND THAT THE MALE TAPER WAS MUCH LARGER THAN THE FEMALE TAPER OF THE EXT. PIECE. WE STRUGGLED THAT IF WE NEED TO REMOVE THE IN-SITU STEM SINCE WE HAD NO IDEA WHY THE TAPER LOOKED DIFFERENT. SOMEHOW A NURSING STAFF SUGGESTED THAT PART OF THE FEMALE TAPER OF THE IN-SITU 80MM EXT. PIECE MIGHT BE PEELED OFF AND COLDWELDED TO THE STEM'S MALE TAPER. THEREFORE THE SURGEONS TRIED TO USE METAL CUTTING DEVICE TO CUT A BIT ON THE TAPER. FINALLY WE MANAGED TO TAKE AWAY THE PEELED OFF PART AND EXPOSED THE ORIGINAL MALE TAPER OF THE STEM BUT IT EXTENDED THE SURGERY FOR ALMOST 3/4 HOURS. CONCLUSION IS THAT EXTENSION PIECE MIGHT HAVE A FAILURE TRUNNION.

  Patient problems: Foreign Body Reaction; Inadequate Osseointegration; Insufficient Information

  MAUDE report 25610317 ↗
• InjuryJan 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S RIGHT KNEE WAS REVISED. A NOTE AT THE BOTTOM OF THE SHEET REPORTS "REVISED FOR INSTABILITY AND POSSIBLE INFECTION". AN MRH KNEE CONSTRUCT WAS REVISED TO AN MRH/ GMRS KNEE CONSTRUCT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9628290 ↗
• MalfunctionFeb 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  EXPLANTATION WAS NECESSARY BECAUSE OF A FISSURE OF THE DISTAL FEMUR. DURING EXPLANTATION, THE INNER BUSHING LOOSENED FROM THE GMRS EXTENSION PIECE. EXTENSION WAS COATED IN (B)(6) 2017. NEW EXTENSION WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 7300580 ↗
• MalfunctionFeb 27, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DURING A REVISION, THE INNER BUSHING LOOSENED FROM THE GMRS EXTENSION PIECE. NEW EXTENSION WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7300567 ↗
• InjuryJan 26, 2018Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IN REPORTING A REVISION OF PATIENT'S LEFT KNEE ON (B)(6) 2018, REP WAS MADE AWARE OF A PREVIOUS REVISION ON (B)(6) 2016 (REP WAS NOT PRESENT FOR PROCEDURE). IN THAT PROCEDURE, AN 80MM EXTENSION PIECE WAS IMPLANTED. ON (B)(6) 2018, A 100MM EXTENSION PIECE WAS EXPLANTED. REP IS UNAWARE OF WHEN THE 80MM EXTENSION PIECE WAS REVISED. THIS EVENT IS FOR REVISION 1 WHICH TOOK PLACE SOME TIME BETWEEN (B)(6) 2016 AND (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 7222700 ↗

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