ATTUNE 1516-50-414Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295052340), received between May 31, 2019 and Aug 23, 2023 — classified as 4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE UPSIZED TIBIAL INSERT DUE TO SOFT TISSUE LAXITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17602942 ↗
• InjuryMay 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11891730 ↗
• InjuryOct 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE POLY WAS SWAPPED ON (B)(6) 2020 DUE TO A SWOLLEN KNEE AND CLOUDY SECRETIONS. DURING THE PROCEDURE, THE SURGEON NOTICED THAT THE PATELLA TENDON WAS RUPTURED AND DID NOT HAVE PROPER QUAD FUNCTION. DUE TO THIS, AS WELL AS THE PRESENCE OF POSSIBLE INFECTION, THE SURGEON DECIDED TO REMOVE ALL IMPLANTS AND PUT IN A STATIC ANTIBIOTIC SPACER UNTIL THE KNEE CAN BE REVISED.

  Patient problems: Edema; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Unspecified Infection

  MAUDE report 10656487 ↗
• InjuryMay 31, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN AND INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8658545 ↗