GMRS 6495-2-105Recalls & reported problems
Howmedica Osteonics Corp. · Bushing for Small Distal Femur · Class 2 · Implant
All models of GMRS (32)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327048841), received between May 21, 2019 and Dec 10, 2024 — classified as 5 injuries.
The most frequently reported specific device problem is “Degraded” (4 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Degraded4
- Device Dislodged or Dislocated1
Patient problems
- Insufficient Information3
- Ambulation or Postural Difficulties2
- Injury2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
InjuryDec 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated
REVISION OF LEFT DISTAL FEMUR GMRS. FOUND THAT BUSHING APPEARED TO NOT BE PRESENT IN PROSTHESIS. REVISED TO NEW COMPONENTS
Patient problems: Insufficient Information
MAUDE report 20896703 ↗InjuryAug 8, 2022Degraded; Degraded
IT WAS REPORTED THAT THE SURGEON REVISED THE AXLE BUSHINGS AND BUMPER AS A RESULT OF EXCESSIVE WEAR.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 15188341 ↗InjuryAug 8, 2022Degraded; Degraded
IT WAS REPORTED THAT THE SURGEON REVISED THE AXLE BUSHINGS AND BUMPER AS A RESULT OF EXCESSIVE WEAR.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information
MAUDE report 15188306 ↗InjuryMay 21, 2019Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO WEAR OF THE POLY COMPONENT. POSSIBLE CAUSE OR CONTRIBUTOR FOR WEAR NOT REPORTED. PATIENT'S ACTIVITY LEVEL IS UNKNOWN. PATIENT WAS REVISED TO POLY COMPONENT OF THE SAME CATALOG NUMBER. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Injury
MAUDE report 8627659 ↗InjuryMay 21, 2019Degraded; Degraded
IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO WEAR OF THE POLY COMPONENT. POSSIBLE CAUSE OR CONTRIBUTOR FOR WEAR NOT REPORTED. PATIENT'S ACTIVITY LEVEL IS UNKNOWN. PATIENT WAS REVISED TO POLY COMPONENT OF THE SAME CATALOG NUMBER. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.
Patient problems: Injury
MAUDE report 8627587 ↗
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, ClassifiedCustom 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 · TerminatedGMRS 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
Other Prosthesis, hip, semi-constrained, metal/polymer, cemented devices
- NA 1365-51-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented753 reports
- NA 1365-50-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented412 reports
- ARTICUL/EZE 1365-21-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 recall280 reports
- ARTICUL/EZE 1365-11-000Depuy (Ireland) · Prosthesis, hip, semi-constrained, metal/polymer, cemented1 death262 reports
- LFIT 6260-9-236Howmedica Osteonics Corp. · Prosthesis, hip, semi-constrained, metal/polymer, cemented256 reports
- PINNACLE GRIPTION 1217-32-052Depuy Orthopaedics, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented2 deaths239 reports
- ELEOS™ 25002111EOnkos Surgical, Inc. · Prosthesis, hip, semi-constrained, metal/polymer, cemented3 deaths230 reports
- Novation 130-36-52Exactech, Inc. · Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented2 recalls124 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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