ATTUNE 1516-20-712Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295045939), received between Jan 10, 2019 and Oct 18, 2022 — 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 16, 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.

• InjuryOct 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED WITH POLY SWAP DUE TO ARTHROFIBROSIS AND FLEXION CONTRACTURE. PCL WAS RELEASED AND THE CR FB POLY WAS EXCHANGED FOR A MEDIAL STABILIZED POLY OF THE SAME SIZE AND THICKNESS. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Adhesion(s); Joint Contracture

  MAUDE report 15626394 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A POLY EXCHANGE WAS DONE FOLLOWING A FALL AND MCL STRAIN. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2017. DOR: (B)(6), 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Fall; Unspecified Musculoskeletal problem

  MAUDE report 13790376 ↗
• InjuryFeb 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. POLY WAS REMOVED AND REPLACED WITH NEW POLY. WASH OUT WAS ALSO COMPLETED. DOI: (B)(6) 2021, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 13539139 ↗
• InjuryDec 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT THE REMOVAL OF ANTIBIOTIC SPACER AND RE-IMPLANTATION OF THE PERMANENT TOTAL LEFT KNEE ARTHROPLASTY, INCLUDING PATELLAR, FEMORAL, TIBIAL COMPONENTS AND POLYETHYLENE INSERT. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH THE ATTUNE KNEE SYSTEM AND SMARTSET BONE CEMENT X 3. ON (B)(6) 2017, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO LOOSENING OF THE TIBIAL COMPONENT, FLEXION INSTABILITY, AND PAIN. THE SURGEON REPORTED THE REMOVAL OF THE TIBIAL COMPONENT WITH A COMBINATION OF DOUBLE AND SINGLE-SIDED RECIPROCATING SAWS. HE NOTED THE FEMORAL COMPONENT WAS REMOVED WITH A DOUBLE-SIDED RECIPROCATING SAW TO DISRUPT THE FEMORAL TO CEMENT INTERFACE. THE SURGEON INDICATED THE PATELLA WAS WELL-FIXED AND WITHOUT SIGNIFICANT DAMAGE, AND NOT REVISED. THE PATIENT WAS IMPLANTED WITH A COMPETITOR SYSTEM AND THERE WERE NO COMPLICATIONS TO THE PROCEDURE. DOI: (B)(6) 2015. DOR: (B)(6) 2017, (RT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9475755 ↗
• InjuryMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PRESENCE OF INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8619373 ↗
• InjuryJan 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: No Code Available; Pain

  MAUDE report 8233539 ↗