ATTUNE 1516-20-808Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295046035), received between Jun 20, 2018 and Sep 22, 2026 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 22, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that surgeon performed I&D poly exchange on an infected knee.DOI: (b)(6) 2021.DOR: (b)(6) 2026.Affected Side: Left.

  Patient problems: Unspecified Infection

  MAUDE report 50854806 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INSTABILITY WITH KNEE POST FALL. LARGE PATIENT. THEY FELL. NO ISSUES WITH DEPUY KNEE PRODUCTS. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 23795043 ↗
• InjuryFeb 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INSERT EXCHANGE DUE TO AN INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 16310585 ↗
• InjuryFeb 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION FOR INSTABILITY. DATE OF IMPLANTATION: (B)(6) 2021, DATE OF REVISION: (B)(6) 2021, (LEFT KNEE). TREATMENT: REVISION OF TIBIAL INSERT.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13472299 ↗
• InjurySep 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO I/D. DOI: (B)(6) 2021, DOR: (B)(6) 2021, (LEFT HIP).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12413256 ↗
• InjuryMar 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SURGEON CONFIRMED HE HAD A PATIENT WITH A PRIMARY ATTUNE FB CR KNEE, RIGHT SIDE, IMPLANTED 2017 IN A RELATIVELY YOUNG, ACTIVE FARMER, WHO PRESENTED WITH PAIN IN NOV 2020. SUBSEQUENT X-RAYS AND CT SCAN HAVE SUGGESTED TIBIAL LYSIS AND LOOSENING, FEMUR LOOKS OK. INFLAMMATORY MARKERS ARE NORMAL. REVISION OCCURRED ON (B)(6) 2021. SURGEON EXPLANTED ATTUNE CRFB SIZE 8, 8MM INSERT AND ATTUNE FB CEMENTED TRAY. THE FEMUR WAS RETAINED, AND NO PATELLA COMPONENT HAS EVER BEEN USED IN THIS PATIENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 11473294 ↗
• MalfunctionMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RECEIVED MEDICAL RECORDS ON 06/06/2018. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. LEFT ATTUNE TOTAL KNEE REVISED TO ADDRESS PAIN, SWELLING, AND ASEPTIC LOOSENING OF THE TIBIAL BASE PLATE, AT THE CEMENT TO IMPLANT INTERFACE. AN INCIDENTAL UNKNOWN ACL SCREW WAS EXPLANTED ALONG WITH THE TIBIAL BASE PLATE AND THE TIBIAL INSERT. THE FEMUR AND PATELLA COMPONENTS WERE RETAINED. DEPUY CEMENT WAS USED IN PRIMARY. DOI: (B)(6) 2015; DOR: (B)(6) 2017; (LEFT KNEE).

  Patient problems: No Code Available; Pain; Swelling

  MAUDE report 9848307 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2015, THE PATIENT UNDERWENT TOTAL LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE PATELLA WAS NOT RESURFACED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. THE PATIENT WAS IMPLANTED WITH DEPUY KNEE SYSTEM AND COMPETITOR BONE CEMENT. UNKNOWN DATE 2015, THE PATIENT UNDERWENT A LEFT KNEE REVISION WITH LINER EXCHANGE, SYNOVECTOMY AND SECONDARY WOUND CLOSURE. THE SURGEON REPORTED SOMETIME AFTER THE PRIMARY SURGERY, THE PATIENT FELL AND SUSTAINED A WOUND DEHISCENCE, AND WAS TAKEN TO SURGERY WHERE A SYNOVECTOMY AND LINER EXCHANGE WAS PERFORMED. DOI: (B)(6) 2015. DOR: UNKNOWN DATE IN 2015. (RT KNEE).

  Patient problems: No Code Available; Wound Dehiscence

  MAUDE report 9327768 ↗
• InjuryJun 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE WELL FIXED AND SHOWED NO SIGNS OF WEAR AND TEAR. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7620062 ↗