BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXETER V40 STEM 44MM NO2

    MDR report key: 2922086 · Received January 11, 2013

    Report

    Report Number
    9616680-2013-90097
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    JDI
    PMA / PMN Number
    K011623
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVAL. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    PATIENT HAS REPORTED THROUGH PHONE CALL TO SALES REP THAT THE HIP STEM HAS BROKEN (B)(6) 2012 AFTER REOPERATION (B)(6) 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18891 EXETER V40 STEM 44MM NO2 IMPLANT JDI STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other| R