ATTUNE 1516-30-612Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295047919), received between Jan 2, 2020 and Dec 31, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 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.

• InjuryDec 31, 2025Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT UNDERWENT A REVISION PROCEDURE AND WAS CONVERTED TO AN ATTUNE TIBIA WITH CEMENTLESS STEM.

  Patient problems: Insufficient Information

  MAUDE report 23934951 ↗
• InjuryOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. AFFECTED SIDE: UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 23356208 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6), 2023, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 18379891 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. THE SURGEON REMOVED AND REPLACED THE FEMORAL, TIBIAL AND INSERT COMPONENTS. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13561957 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9825011 ↗
• InjuryJan 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015: THE PATIENT UNDERWENT A RIGHT TOTAL KNEE ARTHROPLASTY. ATTUNE IMPLANTS WERE UTILIZED WITH DEPUY CEMENT X2. THE PATELLA WAS RESURFACED. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. MEDICAL RECORDS (ON REVISION NOTE) INDICATE A POLY EXCHANGE OCCURRED POST PRIMARY TO ADDRESS INSTABILITY WITHOUT SUCCESS BUT DOES NOT PROVIDE DATE OF REVISION FOR THE POLY EXCHANGE. ON (B)(6) 2017 :THE PATIENT UNDERWENT A REVISION OF THE RIGHT KNEE FOR PAIN, ASEPTIC LOOSENING OF TIBIAL PLATE, NICKEL SENSITIVITY, AND JOINT INSTABILITY ATTRIBUTED TO PCL INSUFFICIENCY. INTRAOPERATIVELY, THE TIBIAL PLATE WAS FOUND LOOSE AT IMPLANT-CEMENT INTERFACE. PATELLA WAS NOT REVISED. ALL OTHER COMPONENTS WERE REPLACED (TIBIAL, INSERT, FEMORAL) WITH A NON-DEPUY REVISION SYSTEM WITH NON-DEPUY CEMENT. NO COMPLICATIONS NOTED IN REVISION. DOI: (B)(6) 2015. DOR: UNKNOWN (INSERT). DOR: (B)(6) 2017, (PRIMARY TIBIAL, UNKNOWN REVISION INSERT, PRIMARY FEMORAL). THIS COMPLAINT CAPTURES THE UNKNOWN REVISION OF THE POLY INSERT. THE REVISION OF (B)(6) 2017 IS CAPTURED ON (B)(4).

  Patient problems: No Code Available

  MAUDE report 9540366 ↗