BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE LINER

    MDR report key: 1983630 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01426
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 DISLOCATION AND DISASSOCIATION OF LINER FROM CUP. METAL DEBRIS WAS ALSO PRESENT, AS WELL AS OSTEOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PINNACLE LINER TOTAL HIP PROSTHESIS JDI DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention