MRS 6485-3-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327048278), received between Jun 6, 2019 and Mar 22, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (3 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 18, 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.

• InjuryMar 22, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  PATIENT COMPLAINED OF LEG PAIN. XRAY SHOWED BENT OR BROKEN FEMUR STEM. REVISION SURGERY PERFORMED WITH NEW STEM.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 13844968 ↗
• InjuryNov 17, 2020Fracture; Failure to Osseointegrate; Fracture; Failure to Osseointegrate

  IT WAS REPORTED BY THE SALES REP THAT THE SURGEON INFORMED OF AN ISSUE OF A BROKEN GMRS STEM ON (B)(6) 2020 (CURRENT STEM DIAMETER 10MM REF 6485-3-000, LN 187138A) AND THE NEED TO REVISE TO A THICKER STEM (11 OR 13MM). CURRENT STEM WAS IMPLANTED ON (B)(6) 2019 (PRIMARY SURGERY). REVISION SURGERY IS PLANNED ON (B)(6) 2020. UPDATE: "SURGEON MENTIONED IMPLANT LIKELY HAVE LOOSENED AND BROKEN DUE TO PATIENT RIDING MOTORCYCLE AND USING HER LEGS TO STOP THE BIKE (EXCESSIVE STRESS TO IMPLANT) PATIENT HAD BROKEN IMPLANT IN (B)(6) 2020 BUT WAS UNABLE TO COME IN DUE TO COVID, HENCE THE DELAY TO (B)(6) SURGERY."

  Patient problems: Ambulation or Postural Difficulties; Inadequate Osseointegration

  MAUDE report 10854626 ↗
• InjuryDec 30, 2019Fracture; Fracture

  GMRS STEM FRACTURE.

  Patient problems: Injury

  MAUDE report 9531981 ↗
• InjuryJun 6, 2019Break; Break

  IT WAS REPORTED THAT THE PATIENT'S LEFT KNEE WAS REVISED DUE TO A BROKEN MRS FEMORAL STEM. THE SURGEON REPORTED THAT THE MOST LIKELY CAUSE OR CONTRIBUTOR WAS THAT THE PATIENT WAS MOVING FURNITURE AT THE TIME. REP PROVIDED PRE- AND POST-REVISION X-RAYS AND EXPLANT PICTURES, AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury

  MAUDE report 8674329 ↗