ATTUNE 1516-20-816Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295046073), received between Oct 20, 2021 and Jan 4, 2022 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC WAS CREATED TO CAPTURE THE ALLEGATION ON. ON (B)(6) 2020, THE PATIENT UNDERWENT A SECOND RIGHT KNEE REVISION TO ADDRESS PAIN, SCAR REMOVAL, AND TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. THE TIBIAL TRAY, TIBIAL INSERT, AND FEMORAL COMPONENT WERE REVISED. THE PATELLA COMPONENT WAS RETAINED. THE PATIENT WAS REVISED WITH COMPETITOR PRODUCTS AND CEMENT. THERE WERE NO INDICATED INTRA-OPERATIVE COMPLICATIONS. TASK INITIATED TO CREATE NEW PC TO CAPTURE SECOND REVISION. DOI: (B)(6) 2016 (TIBIAL INSERT). DOI: (B)(6) 2014 (TIBIAL TRAY, FEMORAL, CEMENT, PATELLA). DOR: (B)(6) 2020 (2ND REVISION RIGHT KNEE).

  Patient problems: Adhesion(s); Pain

  MAUDE report 13156130 ↗
• InjuryOct 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAS HAD MANY HEALTH PROBLEMS. PATIENT WAS PUT ON MANY MEDICATIONS FOR HIS HEART WHICH HE DEVELOPED A SWELLING IN KNEE AND LEG. PATIENT FELL AND STARTED TO FEEL A INSTABILITY IN HIS KNEE. THE SURGEON DIAGNOSIS IS SOFT TISSUE FAILURE, IN WHICH HE WAS BROUGHT TO THE O.R. FOR A WASH OUT OF HIS KNEE AND EXAMINATION OF HIS SOFT TISSUE AND LIGAMENTS. IT WAS DETERMINED THAT THE KNEE WAS LOOSE IN FLEXION DUE TO THE FALL. TRIAL OF THICKER POLYS WAS DETERMINED THAT FROM A TEN TO A 16 MADE THE KNEE STABLE. IT WAS IRRIGATED AND CLOSED WITH THE PATIENT HAVING A FULL RANGE OF MOTION FROM FLEXION TO EXTENSION AND VERY STABLE. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Fall; Joint Laxity; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 12664611 ↗