BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX52OD

    MDR report key: 1983606 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01435
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A SUSPECTED TUMOR BEHIND THE CUP THAT CAUSED LOOSENING OF THE CUP. THE SURGEON DETERMINED THAT PATIENT WAS HAVING A REACTION TO THE METAL-ON-METAL HIP DUE TO THE TISSUE NECROSIS AROUND THE CUP, AND THERE WAS ALSO CORROSION JUST BELOW THE TRUNION OF THE STEM AND THE LARGE CAVITARY DEFECT BEHIND THE CUP. THE SURGEON REMOVED THE PINNACLE CUP AND SROMSTEM, LEAVING THE SROM SLEEVE IN PLACE, AS IT WAS WELL-FIXED. THE SURGEON WILL MOST LIKELY BRING THE PATIENT BACK IN A FEW DAYS AND REPLACE THE ACETABULUM WITH A CAGE-TYPE PROSTHESIS AND A NEW STEM AND HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT36IDX52OD 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2479633

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention