MRS 6485-3-111Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07613327048360), received between Jul 26, 2019 and Dec 15, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2022Loss of Osseointegration; Loss of Osseointegration

  A PATIENT SPECIFIC IMPLANT REQUEST FORM WAS RECEIVED FOR THE PATIENT'S DISTAL FEMUR/ PROXIMAL TIBIA REPLACEMENTS. "FAILURE OF DISTAL TIBIAL CEMENTED STEM DUE TO LOOSENING." ALL COMPONENTS TO BE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15986005 ↗
• InjuryOct 20, 2022Loss of Osseointegration; Loss of Osseointegration

  DISTAL FEMUR GMRS WAS REVISED DUE TO LOOSENING OF THE STEM. SURGEON REPORTED PATIENT HAD STUMBLED AND POSSIBLY FALLEN OVER. ON OPENING THE PATIENT, SURGEON NOTED THE CEMENT MANTLE WAS IN PIECES.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15638373 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2022, IT WAS REPORTED BY STRYKER SALES REP THAT THE SURGEON INFORMED THE EXTRACTION OF IMPLANTS BY (B)(6) 2022 DUE TO INFECTION. REVISION WAS IN YEAR 2017.

  Patient problems: Unspecified Infection

  MAUDE report 13843807 ↗
• InjurySep 11, 2019Break; Break

  BROKEN PROXIMAL FEMUR DISTAL STEM GMRS. PT PRESENTED WITH PAIN AND INSTABILITY. UPDATE 15/AUGUST/2019 WG: AS REPORTED IN ADVERSE CONSEQUENCES DETAILS "PATIENT NEEDED REVISION SURGERY TO COMPENSATE FOR BREAKAGE." AN OPERATIVE REPORT, PRE-REVISION X-RAY, AND EXPLANT PICTURE ARE PROVIDED.

  Patient problems: Injury

  MAUDE report 8991783 ↗
• InjuryJul 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "FEMORAL COMPONENTS WERE REVISED DUE TO PERFORATION OF THE FEMORAL CORTEX BY THE INTRAMEDULLARY STEM. NO OTHER COMPLAINTS REPORTED". SPOKE TO REP. POSSIBLE CAUSE OR CONTRIBUTOR FOR PERFORATION NOT REPORTED TO REP. A REVISION USAGE SHEET WITH GMRS/ MRS COMPONENTS (DISTAL FEMUR, AXLE, BUMPER INSERT, LONG CURVED CEMENTED STEM, BUSHING) WAS PROVIDED. REP REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Perforation

  MAUDE report 8830762 ↗