BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALUMINA HEAD

    MDR report key: 1851106 · Received September 29, 2010

    Report

    Report Number
    9616680-2010-00607
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    December 6, 2007
    Report Date
    August 10, 2010
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM A RETROSPECTIVE (B)(4) STUDY. SITES ARE ONLY REQUIRED TO REPORT PER THEIR MILESTONES AS SIGNIFICANT AMOUNT OF TIME AFTER REVISIONS OCCURRED, AND THEREFORE, WE DO NOT KNOW IF THE DEVICE WILL BE AVAILABLE. IF ADDITIONAL INFO BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    REVISED DUE TO DISLOCATION. FROM A RETROSPECTIVE (B)(4) STUDY. SITES ARE ONLY REQUIRED TO REPORT PER THEIR MILESTONES AS SIGNIFICANT AMOUNT OF TIME AFTER REVISIONS OCCURRED, AND THEREFORE, WE DO NOT KNOW IF THE DEVICE WILL BE AVAILABLE. INITIAL SURGERY (B)(6) 2005, REVISION (B)(6) 2007.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALUMINA HEAD IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention