ATTUNE 1516-51-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295053156), received between Dec 3, 2019 and Dec 3, 2019 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017 THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO INSTABILITY AND PAIN. THE SURGEON REPORTED FEMORAL COMPONENT WAS SOLID, THOUGH REVISED. HE NOTED HE FELT CONVERTING THE PATIENT TO A FULL TC 3 DISTAL FEMUR WOULD MATCH UP WITH THE MBT TRAY TO GIVE MORE CONSTRAINT. THE SURGEON INDICATED THE PATELLA TRACKED CENTRALLY AND WAS RETAINED. NEITHER THE TIBIAL NOR PATELLAR COMPONENTS WERE REVISED. THE PATIENT WAS IMPLANTED WITH DEPUY FEMORAL SYSTEM, TIBIAL INSERT, AND UNKNOWN BONE CEMENT. DOI: (B)(6) 2014 (FEMORAL COMPONENTS AND BONE CEMENT). DOI: (B)(6) 2016 (TIBIAL INSERT). DOR: (B)(6) 2017 (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9405107 ↗