BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 32MM +1

    MDR report key: 1984500 · Received January 28, 2011

    Report

    Report Number
    1818910-2011-01255
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    December 30, 2010
    Report Date
    December 30, 2010
    Manufacturer
    DEPUY INTL., LTD.
    Product Code
    LZO
    PMA / PMN Number
    K031803
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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

    PT REVISED FOR DISLOCATION. WASTED LINER DURING IMPLANTATION, TABS BENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA CER HEAD 12/14 32MM +1 87 LZO LZO DEPUY INTL., LTD. NA 2935363

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention