BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA V-40 CERAMIC HEAD 36/+2,5

    MDR report key: 3870596 · Received June 12, 2014

    Report

    Report Number
    0002249697-2014-02241
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    March 25, 2011
    Report Date
    May 21, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K052718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT TOTAL HIP ARTHROPLASTY REVISION DUE TO PJI (PROSTHETIC JOINT INFECTION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348528 DELTA V-40 CERAMIC HEAD 36/+2,5 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R