GMRS 6495-6-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327049169), received between Jul 7, 2020 and Aug 25, 2026 — classified as 5 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 (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.

• InjuryAug 25, 2026Material Erosion

  It was reported through the filing of a lawsuit that allegedly the patient was implanted with an LFIT Anatomic CoCr V40 Femoral Head on his left hip on or about (b)(6) 2014 and was revised on (b)(6) 2024. It is further alleged that he suffered injuries as a result of implantation and explantation of the device at issue, device recall, and excessive levels of cobalt and chromium in his blood.

  Patient problems: Metal Related Pathology

  MAUDE report 50436793 ↗
• InjuryOct 20, 2025Unstable; Unstable

  IT WAS REPORTED BY THE CUSTOMER THAT "SMALL GMRS FEMORAL COMPONENT EXPERIENCED POLYETHYLENE WEAR FAILURE OF THE BUMPER AXLE BUSHINGS. SOME WEAR WAS OBSERVED ON THE SMALL GMRS FEMORAL COMPONENT AND THE SMALL GMRS ROTATING COMPONENT. FRETTING CORROSION WAS OBSERVED ON THE TRUNNION AND TAPER OF THE 40MM GMRS EXTENSION PIECE LINKING THE SMALL GMRS PROXIMAL TIBIA AND KOTZ TO GMRS ADAPTOR. THE EXTENSION PIECE WAS EASY TO REMOVE FROM THE ADAPTOR BUT EXTREMELY DIFFICULT TO REMOVE FROM THE PROXIMAL TIBIA. BLACKENED FLAKES OBSERVED AT TIBIAL TRUNIONS." PATIENT PRESENTED WITH INSTABILITY OF THE KNEE 15 YEARS AFTER THE COMPONENTS WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 23334676 ↗
• 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 19583662 ↗
• 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 19496989 ↗
• InjuryJul 7, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON THE PATIENT'S LEFT KNEE DUE TO ELEVATED TITANIUM IONS. INTRA-OPERATIVELY, SURGEON REPORTED THAT THE TITANIUM FEMORAL STEM WAS LOOSE. THE PATIENT'S ENTIRE MRH CONSTRUCT WAS REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inflammation; Injury; Reaction

  MAUDE report 10238338 ↗

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