GMRS 6495-2-010Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07613327048797), received between Sep 12, 2017 and Sep 9, 2026 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of Osseointegration” (5 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Degraded

  It was reported that the patient presented with poly failure and wear as well as apparent metallosis of GMRS taper junctions which was noticed upon patella fracture treatment.

  Patient problems: Foreign Body Reaction

  MAUDE report 50690352 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ARTHROFIBROSIS. ABOVE KNEE AMPUTATION PERFORMED. LEFT KNEE.

  Patient problems: Arthrofibrosis

  MAUDE report 22735532 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PI IS FOR THE SURGICAL INTERVENTION FOR ARTHROFIBROSIS. INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: WOUND INFECTION SUSPECTED (B)(6) 2013, IV VANC, NO RETURN TO OR. LATER NEEDED TO BE ON LIFELONG ORAL ANTIBIOTICS FOR CHRONIC SUPPRESION. SURGICAL INTERVENTION FOR ARTHROFIBROSIS (B)(6) 2015. LEFT KNEE.

  Patient problems: Arthrofibrosis

  MAUDE report 22724382 ↗
• InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22713830 ↗
• InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM (B)(4) INDICATES THE FOLLOWING: ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22713679 ↗
• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  INFORMATION RECEIVED FROM IIS 2023-001 INDICATES THE FOLLOWING: ASEPTIC LOOSENING. FEMORAL COMPONENT REVISED. LEFT KNEE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22680674 ↗
• InjuryJul 31, 2025Loss of Osseointegration; Loss of Osseointegration

  THE FOLLOWING WAS REPORTED: "ASEPTIC LOOSENING. ALL COMPONENTS REMOVED. LEFT KNEE."

  Patient problems: Inadequate Osseointegration

  MAUDE report 22680520 ↗
• InjuryMar 19, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: PATIENT WAS REVISED DUE TO LOOSEN FEMORAL COMPONENT. NO OTHER INFORMATION AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 21641660 ↗
• InjuryJan 30, 2024Degraded; Material Erosion; Degraded; Material Erosion

  IT WAS REPORTED THAT DURING A REVISION OF GMRS/MRH, TRUNNIONOSIS WAS SEEN ON THE GMRS TAPER JUNCTIONS. PRIOR TO REVISION, PREOPERATIVE JOINT ASPIRATION YIELDED DARK FLUID CONSISTENT WITH METALLOSIS.

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction

  MAUDE report 18605226 ↗
• InjuryJun 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PT. PRESENTED WITH A TENDON-RUPTURE OF THE PATELLAR-TENDON/EXTENSOR-MECHANISM. THE DOCTOR OPTED TO SWAP OUT SOME COMPONENTS, WHILE PERFORMING AN I&D, AND EXTENSOR-MECHANISM REPAIR. NO COMPLAINTS HAVE BEEN FILED AGAINST THE COMPONENTS THEMSELVES. NO FURTHER INFO AVAILABLE."

  Patient problems: Muscle/Tendon Damage

  MAUDE report 17069109 ↗
• InjuryJun 16, 2022Failure to Osseointegrate; Failure to Osseointegrate

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED. AS REPORTED: "PT. PRESENTED WITH TIBIAL TENDERNESS/PAIN CONSIDERED INDICATIVE OF A LOOSE CEMENTED-IMPLANT. IMAGING RESULTS LEAD SURGEON TO REVISE THE PATIENT¿S GMRS DISTAL-FEMUR CONSTRUCT. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES." SPOKE TO REP, WHO PROVIDED USAGE SHEETS. NOTHING WAS OBSERVED INTRA-OPERATIVELY TO BE WORN OR BROKEN. REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 14723084 ↗
• MalfunctionMay 10, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  PRIMARY PROCEDURE, LEFT FEMUR. IT WAS REPORTED THAT IN OPENING THE IMPLANT, A FINE WHITE POWDER WAS WITNESSED ON THE IMPLANT. DUE TO STERILITY CONCERNS, THE IMPLANT WAS NOT USED. ANOTHER IMPLANT WAS SECURED AND OPENED WHILE THE CEMENT WAS SETTING, WITH NO SURGICAL DELAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7502468 ↗
• InjurySep 12, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT UNDERWENT AN INDEX AND REVISION SURGERIES OUTSIDE ROTHMAN INSTITUTE. ON (B)(6) 2017, THE PATIENT WAS REVISED FOR TKA LOOSENING. WITH EXCHANGE OF ALL COMPONENTS TO A HINGE TKA. 5 MONTHS LATER A NEW REVISION IS PERFORMED FOR INSTABILITY, EXCHANGED ALL ROTATING HINGE COMPONENTS, AND DISTAL FEMORAL COMPONENT.

  Patient problems: Injury

  MAUDE report 6859829 ↗

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