ATTUNE 1516-30-308Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295047537), received between Nov 10, 2020 and Apr 27, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Inaccurate Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Inaccurate Information; Inaccurate Information

  IT WAS REPORTED THAT THE IMPLANT ARRIVED WITH THE CELLOPHANE, BUT WHEN WE OPENED THE BOX WE NOTICED THAT THE LABELS DID NOT MATCH THE BOX. FOR THIS REASON, THE IMPLANT WAS NOT OPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14218895 ↗
• InjuryNov 24, 2020Unintended Movement; Unintended Movement

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND INSERT ROTATED 90 DEGREES. THERE WAS NO FALL NOR TRAUMA RELATED TO THE EVENT. IT WAS DETERMINED THAT THE LATERAL COLLATERAL LIGAMENT HAD PULL AWAY FROM THE FEMUR CREATING INSTABILITY. THE FEMORAL COMPONENT WAS REMOVED AND REPLACED WITH A POSTERIOR STABILIZED FEMORAL COMPONENT AND INSERT. NO SURGICAL DELAY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 10895285 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10815800 ↗