MRS 6485-3-811Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327049787), received between Aug 23, 2018 and Aug 26, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2025Osseointegration Problem; Osseointegration Problem

  REVISION OF DISTAL FEMORAL GMRS, TO TOTAL FEMUR GMRS. GMRS REVISED DUE TO LOOSENING. NOTIFICATION OF REVISION ONLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22892453 ↗
• InjuryNov 20, 2020Material Twisted/Bent; Material Twisted/Bent

  GMRS DISTAL FEMUR STEM 11X127 HAS BEEN BENT. LEFT SIDE.

  Patient problems: Insufficient Information

  MAUDE report 10874106 ↗
• InjuryJun 27, 2019Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S FEMUR WAS REVISED DUE TO THE STEM FRACTURING NEAR THE SEAT OF THE STEM AT THE BONE JUNCTION. PATIENT WAS REVISED TO A TOTAL FEMUR.

  Patient problems: Injury

  MAUDE report 8738916 ↗
• InjuryAug 23, 2018Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT PATIENT'S RIGHT KNEE WAS REVISED DUE TO A BROKEN STEM (BREAK WAS AT TAPER JUNCTION PLUS 2 CM). NO TRAUMA WAS REPORTED BUT THE PATIENT IS A VERY ACTIVE FARMER. PATIENT WAS REVISED BY RESECTING THE FEMUR FURTHER UP AND PLACING A GMRS 160MM STEM.

  Patient problems: Injury; Osteolysis

  MAUDE report 7808995 ↗