BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PRODUCT - REUNION SHOULDER HEAD AND STEM

    MDR report key: 1861839 · Received October 5, 2010

    Report

    Report Number
    2249697-2010-01316
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWS
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO WAS REQUESTED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "PT WAS SENT HOME AFTER THE CASE WHICH OCCURRED LATE (B)(6) APPROX. ABOUT TWO WEEKS LATER, THE PT PRESENTED FOR A F/U AND IT WAS FOUND THAT THE HEAD DISASSOCIATED FROM THE STEM. REVISION WILL OCCUR (B)(6) 2010".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN PRODUCT - REUNION SHOULDER HEAD AND STEM IMPLANT KWS STRYKER ORTHOPAEDICS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention