GMRS 6495-1-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327048704), received between Nov 9, 2017 and Feb 6, 2025 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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.

• InjuryFeb 6, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT APPEARS THAT THE PATIENT RECEIVED A GMRS HIP REPLACEMENT IN MID-2024. THE PATIENT COMPLAINS OF MUSCLE PAIN AND MUSCLE TENSION, AMONG OTHER ISSUES. THE PATIENT IS CONCERNED THAT HE IS ALLERGIC TO THE IMPLAN.T

  Patient problems: Muscle/Tendon Damage

  MAUDE report 21320256 ↗
• InjuryFeb 29, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION RTHA- DISSOCIATED CONSTRAINED LINER FROM CUP. REVISING TO ANOTHER CONSTRAINED LINER AND CHANGING THE PROXIMAL FEMUR COMPONENT STANDARD TO ANTEVERTED COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 18809583 ↗
• InjuryJun 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT TOTAL FEMUR WAS REVISED. AS REPORTED: "PT. PRESENTED WITH SYMPTOMS OF AN ACUTE INFECTION, LAB-WORK AND IMAGING DETERMINED THE PATIENT HAD AN ACUTE INFECTION OF THE LEFT-THIGH. SURGEON PERFORMED AN I&D OF THE PATIENT¿S THIGH AND HIP AND DETERMINED IT¿D BE BEST TO EXTEND THE INCISION DOWN TO THE KNEE TO ENSURE PROPER I&D OF THE PATIENT¿S GMRS TOTAL-FEMUR CONSTRUCT. SURGEON REPLACED ALL COMPONENTS LISTED ON THE ORIGINAL SURGERY-SHEET EXCEPT FOR THE ALL-POLY TIBIAL COMPONENT. IT WAS CONSIDERED WELL FIXED AND LEFT IN-SITU. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES."

  Patient problems: Unspecified Infection

  MAUDE report 14780547 ↗
• 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 9628284 ↗
• MalfunctionNov 9, 2017Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT IN REVISING PATIENT'S RIGHT HIP, REP DISCOVERED THAT THE INNER PACKAGING OF THE INTENDED IMPLANT WAS COMPROMISED. THE OUTER BOX AND OUTER PACKAGING WERE REPORTED TO BE INTACT AND IN GOOD CONDITION. SURGEON ELECTED TO NOT USE THE IMPLANT DUE TO STERILITY CONCERNS AND INSTEAD REVISED PATIENT TO A PROXIMAL FEMORAL DEVICE WITH A TROCHANTER. AS THIS IMPLANT IS LARGER THAN THE INTENDED IMPLANT, SURGEON REPORTED DIFFICULTY IN CLOSING THE WOUND AS A SOFT TISSUE ENVELOPE HAD FORMED AROUND THE ORIGINAL IMPLANT. REP REPORTED A SURGICAL DELAY OF APPROXIMATELY 3 MINUTES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7014248 ↗

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