ATTUNE 1516-20-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295045441), received between Sep 14, 2017 and Jan 16, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED FEELINGS OF INSTABILITY. REVISION OF POLY SWAP TO A THICKER AND MA INSERT. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 21169996 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HYPER EXTENSION AND INSTABILITY. GOING IN WITH A HINGE. NO DELAY IN SURGERY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12512354 ↗
• InjuryFeb 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2016: PATIENT UNDERWENT A LEFT KNEE REPLACEMENT DUE TO OSTEOARTHRITIS. ATTUNE PRIMARY IMPLANTS WERE IMPLANTED WITH DEPUY CEMENT. NO INTRA-OPERATIVE COMPLICATIONS NOTED. PATIENT PRESENTED WITH PAIN, SWELLING, AND INSTABILITY. RADIOGRAPHS REVEALED FAILURE OF THE TIBIAL COMPONENT WITH SIGNIFICANT LOOSENING, LOSS OF ALIGNMENT, AND BONE LOSS. REVISION SURGERY WAS RECOMMENDED, BUT THE PATIENT REQUIRED SIGNIFICANT OPTIMIZATION TO MINIMIZE HER RISK PROFILE. DURING THAT TIME HER WEIGHT BEARING WAS PROTECTED IN A BRACE, ALTHOUGH THERE WERE ISSUES WITH NON-COMPLIANCE. SHE ALSO EXPERIENCED A GI BLEED WHICH REQUIRED BLOOD TRANSFUSION AND FURTHER TREATMENT. SHE ULTIMATELY FRACTURED HER MEDIAL TIBIAL CONDYLE WARRANTING AN URGENT REVISION SURGERY. IT SHOULD BE NOTED THE PATIENT WAS DIAGNOSED WITH A UTI PRIOR TO THE OPERATION AND WAS PROVIDED TREATMENT TO MINIMIZE HER INFECTION RISK. ON (B)(6) 2019: PATIENT UNDERWENT A LEFT KNEE REVISION. FINDINGS DURING THE SURGERY WERE WELL FIXED FEMORAL COMPONENT, GROSSLY LOOSE TIBIAL COMPONENT-CEMENT TO IMPLANT INTERFACE, TIBIAL DEFECT WITH A MEDIAL AND LATERAL CONDYLE FRACTURE-PLATE AND SCREWS PLACED, AND WELL-FIXED PATELLA COMPONENT (RETAINED). COMP

  Patient problems: Edema; No Code Available; Pain; Unspecified Infection

  MAUDE report 9665084 ↗
• InjurySep 14, 2017Fracture; Naturally Worn; Fracture; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS POLY WEAR ON THE LEFT MEDIAL SIDE AND SOME SMALL PIECES HAVE BROKEN OFF. IT HAS ALSO NOTED SOME SUBSTANTIAL POLYETHYLENE FAILURE. TIBIAL TRAY APPEARED TO BE WELL FIXED ON X- RAY. IN THEATRE THE TRAY WAS REMOVED WITH 4 OR 5 STRONG TAPS OF CHISEL AND APPEARED ¿CLEAN ON ITS UNDERSIDE, CEMENT MANTLE WAS FULLY FIXED IN PATIENTS TIBIA.

  Patient problems: No Consequences Or Impact To Patient; No Information

  MAUDE report 6864396 ↗