GMRS 6495-1-201Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327048735), received between Jun 29, 2017 and Dec 20, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K032581, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISSOCIATION OF A COMPETITOR'S CONSTRAINED LINER FROM A COMPETITOR SHELL. THE LINER AND A STRYKER FEMORAL HEAD AND FEMORAL COMPONENT WERE REVISED. AS REPORTED: "OPTED TO CHANGE THE GMRS PROXIMAL-FEMUR COMPONENT AND HEAD OPTION TO MATCH A DIFFERENT LINER-OPTION THAN THE LAST REVISION." REP CONFIRMED THAT THERE WERE NO ALLEGATIONS AGAINST THE REVISED STRYKER IMPLANTS AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Insufficient Information

  MAUDE report 16018118 ↗
• MalfunctionNov 11, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  THIS PI IS FOR THE INTRA-OPERATIVE EVENT. IT WAS REPORTED THAT WHILE PERFORMING A REVISION ON THE PATIENT'S RIGHT HIP, A GMRS PROXIMAL FEMORAL STANDARD COMPONENT WAS OPENED AND OBSERVED TO HAVE WHITE FLECKS ON IT. THE IMPLANT ITSELF APPEARED TO HAVE DAMAGE TO IT. REP REPORTED THE PACKAGING DID NOT APPEAR TO HAVE ANY DAMAGE. A GMRS PROXIMAL FEMORAL TROCHANTERIC DEVICE WAS IMMEDIATELY AVAILABLE IN THE O.R. AND USED TO COMPLETE THE CASE WITH NO SURGICAL DELAY. REP PROVIDED PICTURES OF THE DEVICE AND PACKAGING AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305883 ↗
• MalfunctionJun 29, 2017Device Operates Differently Than Expected; Device Operates Differently Than Expected; Device-Device Incompatibility

  COMPANY REP REPORTED THAT DURING TRAILING THE IMPLANT AND TRIAL DID NOT MATCH. SURGEON OPENED ANOTHER IMPLANT AND COMPLETED SURGERY SUCCESSFULLY. THE SURGEON STATED THAT THE TRIALS HAD ROTATED THE FEMUR INTO EXTERNAL ROTATION BUT THE REAL IMPLANT HAD PUSHED IT INTO INTERNAL ROTATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6679674 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K032581, 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;