ATTUNE 1516-50-714Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295052760), received between Sep 5, 2019 and Feb 15, 2024 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY SWAPPED DUE TO CONSTRAINED FOR INSTABILITY. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 18715213 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED FOR PATELLA FRACTURE DUE TO FALL. DOI: (B)(6), 2022. DOR: (B)(6), 2023. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Fall

  MAUDE report 18442472 ↗
• InjuryApr 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 16682935 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D FOR HEMATOMA. POLY WAS EXCHANGED FOR PRECAUTION. NO PROBLEM WITH THE PRODUCT. NO INSTABILITY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Hematoma

  MAUDE report 15605527 ↗
• InjuryDec 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR STIFFNESS, RIGHT TKA, SO MANIPULATION UNDER ANESTHESIA: ADHESIONS. EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. THERE IS A REMOTE POSSIBILITY THE EVENT IS RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE). DEPUY COMPONENTS USED IN PROCEDURE WITHOUT DATE OF REVISION: CATALOG ID: 150410107. LOT: 8144922. DESCRIPTION: ATTUNE POST/STAB FEM LT SZ 7 CEMENTED. CATALOG ID: 151810032. LOT: 9102726. DESCRIPTION: ATTUNE MEDIAL ANAT PAT 32MM. CATALOG ID: 150680008. LOT: 9168128. DESCRIPTION: ATTUNE ROTATING PLATFORM TIBIAL BASE SIZE 8 CEMENTED. CATALOG ID: 151650710. LOT: 9099637. DESCRIPTION: ATTUNE PS/RP INSERT SZ 7 10MM.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9430339 ↗
• InjurySep 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2017, THE PATIENT UNDERWENT A SECOND-STAGE RIGHT KNEE REVISION AFTER INFECTION WAS CLEARED. THE SURGEON NOTED SCARRING AND FIBROUS TISSUE. DEFINITIVE PRODUCTS WERE IMPLANTED. DOI: (B)(6) 2017; DOR: (B)(6) 2017, RIGHT KNEE.

  Patient problems: Fibrosis; No Code Available; Scarring

  MAUDE report 8966729 ↗