ATTUNE 1516-51-007Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295053149), received between Oct 4, 2019 and Nov 20, 2024 — classified as 2 injuries.

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

• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS LOOSE IN EXTENSION AND A LITTLE IN FLEXION. IT WAS DECIDED TO TAKE THE PATIENT TO SURGERY AND PUT IN A LARGER POLY; POLY WENT FROM A 7MM TO A 14MM AND SAID HIS RANGE OF MOTION WAS BETTER IN BOTH. THE SURGEON DID NOT SEE ANYTHING WRONG WITH THE OTHER COMPONENTS AND DID NOT SEE A REASON TO REVISE ANYTHING OTHER THAN THE POLY. IT WAS NOTED THE POLY ITSELF WAS NOT LOOSE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Loss of Range of Motion

  MAUDE report 20734712 ↗
• InjuryOct 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 17 JUNE 2019. THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO INSTABILITY. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS NOT REVISED. DEPUY CEMENT WAS USED DURING THE PRIMARY OPERATION. DOI: (B)(6) 2015. DOR: (B)(6) 2017. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9155990 ↗