BEUDAMED
    FDA Adverse Event Other Summary report: N

    DELTA HIP

    MDR report key: 1880538 · Received October 20, 2010

    Report

    Report Number
    1644408-2010-00551
    Event Type
    Other
    Date Received
    October 20, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 11, 2010
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    LZO
    PMA / PMN Number
    K082844
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY - INFECTION OCCURRED ON THE WOUND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DELTA HIP FEMORAL CERAMIC HEAD LZO ENCORE MEDICAL, L.P. 53983253

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention LOT 54034738| 931-36-252