BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MULTIHOLE W/GRIPTION 54MM

    MDR report key: 2002141 · Received February 18, 2011

    Report

    Report Number
    1818910-2011-02645
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 21, 2011
    Report Date
    January 21, 2011
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K093646
    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 REVISED FOR LOOSE ACETABULAR CUP. HEAD MFG BY OTHERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINN MULTIHOLE W/GRIPTION 54MM 87 LPH, KWA, JDI, LZO LPH DEPUY ORTHOPAEDICS, INC. NA E41DTA000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention