BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +1.5

    MDR report key: 1020282 · Received March 25, 2008

    Report

    Report Number
    1818910-2008-00952
    Event Type
    Injury
    Date Received
    March 25, 2008
    Date of Event
    October 10, 2007
    Report Date
    February 25, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LZO
    PMA / PMN Number
    K073504
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    PT REVISION SURGERY SHOWED SEVERAL CERAMIC-CHIPS. CERAMIC HEAD AND CHIPS HAVE BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CER HEAD 12/14 36MM +1.5 87KWA LZO DEPUY ORTHOPAEDICS, INC. NA 2130340

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention