MRS 6485-3-117Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07613327048384), received between Sep 26, 2018 and Aug 21, 2020 — classified as 1 injury, 1 malfunction.

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

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryAug 21, 2020Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT'S RIGHT FEMUR WAS REVISED DUE TO A FEMORAL SHAFT PERIPROSTHETIC FRACTURE. A 17 X 127 STEM AND CEMENT PLUG WERE REVISED TO A 13 X 127 STEM AND TWO EXTENSION PIECES. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Bone Fracture(s); Injury

  MAUDE report 10436688 ↗
• MalfunctionSep 26, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  PRIMARY PROCEDURE, PROXIMAL FEMUR. AS REPORTED: "WE OPENED THE IMPLANT BOX, SURGICAL TECH PEELED BACK THE PROTECTIVE PACKAGING AND SHE AND THE SURGEON NOTICED WHITE SPECS...ON THE IMPLANT IMMEDIATELY UPON OPENING. THE SURGEON THEN ASKED FOR A NEW IMPLANT TO BE OPENED. THE PER IMPLANT NEVER WAS REMOVED FROM THE [INNER STERILE TRAY], NEVER WAS IMPLANTED, AND NEVER TOUCHED THE PATIENT". REP REPORTED THERE WAS NO SURGICAL DELAY IN PROVIDING A SECOND IMPLANT. REP WAS PRESENT FOR THE PROCEDURE. NONE OF THE PACKAGING EXCEPT THE INNER STERILE TRAY WAS RETAINED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7911788 ↗