GMRS 6495-2-020Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 07613327048759), received between Feb 2, 2018 and Oct 20, 2025 — classified as 10 injuries.

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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Loss of Osseointegration; Malposition of Device; Loss of Osseointegration; Malposition of Device

  NO NEW INFORMATION.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23334720 ↗
• 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: PJI. ABOVE KNEE AMPUTATION PERFORMED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22740211 ↗
• 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: PJI. FEMORAL COMPONENTS REVISED. RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22737323 ↗
• InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 22716273 ↗
• InjuryAug 5, 2025Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration

  MAUDE report 22713675 ↗
• InjuryFeb 26, 2025Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT HAD A RIGHT KNEE REVISION DUE TO A LOOSE FEMORAL COMPONENT. NO ADDITIONAL INFORMATION WILL BE MADE AVAILABLE DUE TO HOSPITAL POLICY.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 21466954 ↗
• InjuryJun 14, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  POSTOPERATIVELY, THE GMRS DISTAL FEMORAL COMPONENT WAS DISLODGED FROM THE STEM. ADDITIONAL INFORMATION: "AS FOR THE POSTOPERATIVE COURSE, CLEANSING DEBRIDEMENT WAS PERFORMED UNDER LOCAL ANESTHESIA FOR SUPERFICIAL INFECTION OF THE POSTOPERATIVE WOUND. AFTER THAT, THE PATIENT FELL AND THE WOUND WAS OPENED AGAIN AND THE WOUND WAS RE-SUTURED. WHEELCHAIR SELF-PROPELLED AND DISCHARGED. AT THE END OF (B)(6) 2023, THE PATIENT HAD RIGHT KNEE PAIN WHEN TAKING A SHOWER AND WHEN SHE UNDERWENT AN EXAMINATION IN MAY, IT WAS CONFIRMED THAT THE IMPLANT HAD FALLEN OUT. IN ADDITION, RECURRENCE OF OSTEOSARCOMA WAS RECOGNIZED FROM THE TISSUE DURING REVISION SURGERY."

  Patient problems: Insufficient Information

  MAUDE report 17123930 ↗
• InjurySep 18, 2020Loss of Osseointegration; Loss of Osseointegration

  IT WAS REPORTED THAT THE PATIENT'S RIGHT KNEE WAS REVISED DUE TO INFECTION AND LOOSENING OF THE DISTAL FEMUR. A DISTAL FEMUR, 13X127 STEM, BUSHINGS, BUMPER, AXLE, 10MM INSERT, ROTATING PLATFORM, AND SLEEVE WERE REVISED. REP PROVIDED THE PRIMARY USAGE SHEET AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Inadequate Osseointegration; Pain; Post Operative Wound Infection

  MAUDE report 10556436 ↗
• InjuryOct 21, 2019Mechanical Problem; Mechanical Problem

  PROCEDURE: THE PATIENT HAD RIGHT KNEE REPLACEMENT OUTSIDE CORS SCOPE. PATIENT UNDERWENT RIGHT KNEE REVISION WITH DISTAL FEMORAL REPLACEMENT ON (B)(6) 2017. PATIENT UNDERWENT REVISION OF RIGHT DISTAL FEMORAL REPLACEMENT FOR MECHANICAL COMPLICATION ON (B)(6) 2019.

  Patient problems: Injury

  MAUDE report 9214549 ↗
• InjuryFeb 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO POSSIBLE INFECTION (PATHOLOGY CONFIRMED THE ABSENCE OF INFECTION). INTRA-OPERATIVELY, EXCESSIVE FLUID AND POSSIBLY NECROTIC TISSUE WERE OBSERVED.

  Patient problems: Injury; Necrosis Of Flap Tissue

  MAUDE report 7238391 ↗

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