ATTUNE 1516-50-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295052180), received between Jun 8, 2020 and Jun 30, 2025 — classified as 5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO UPSIZE POLY FOR KNEE STABILITY DUE TO LIGAMENT INSUFFICIENCY. DOI: UNKNOWN DOR: JUNE 11,2025 AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 22358872 ↗
• InjuryAug 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17511022 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. THE PATIENT RECENTLY COMPLAINED OF KNEE PAIN AFTER HAVING GONE SEVERAL YEARS PAIN FREE. BONE SCAN INDICATED A POTENTIALLY LOOSE TIBIA. THE SURGEON DECIDED TO ASSESS THE FIXATION OF THE TIBIAL TRAY, HE DESCRIBED IT AS NEITHER LOOSE NOR WELL FIXED. WITH A MILD BLOW WITH A MALLET AND BONE TAMP, THE TRAY WAS REMOVED. NO CEMENT REMAINED ATTACHED TO THE MEAL TRAY. SURGEON QUESTIONS THE FIXATION OF THE FIRST GENERATION ATTUNE TRAYS. DOI: (B)(6) 2015, LEFT KNEE.

  Patient problems: Adhesion(s); Pain

  MAUDE report 14874147 ↗
• InjuryMar 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN TKA. DOI: UNKNOWN; DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Pain

  MAUDE report 11424232 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RECEIVED LEFT PRIMARY ATTUNE TKA TO TREAT END-STAGE OSTEOARTHRITIS. THE PATELLA WAS RESURFACED, AND DEPUY CEMENT X 2 WAS UTILIZED. THE SURGEON NOTED THAT THE PATIENT HAD POSTEROLATERAL INSUFFICIENCY DUE TO AN OLD ACL INJURY AND THAT THE POPLITEUS TENDON WAS ABSENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVE A LEFT TOTAL REVISION TO TREAT PAIN AND INSTABILITY. UPON ENTERING THE JOINT, THE SURGEON CONFIRMED GROSS INSTABILITY OF THE LEFT KNEE. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE WELL-FIXED BUT REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE EXPLANTED TIBIAL INSERT. THE PATELLA WAS RETAINED. THE SURGEONS NOTE THE PATELLAR TENDON WAS THINNING AT THE TIBIAL TUBERCLE AND WAS REATTACHED WITH SUTURE. THE PATIENT RECEIVED COMPETITOR REVISION PRODUCTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2015. DOR: (B)(6) 2016. LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10130014 ↗