BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 STD OFF

    MDR report key: 1923621 · Received December 9, 2010

    Report

    Report Number
    1818910-2010-09509
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 DAY AFTER PRIMARY TO CORRECT SIZE OF IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUMMIT POR TAPER SZ6 STD OFF 87 LPH LPH DEPUY ORTHOPAEDICS, INC. NA E33FKC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention