BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8

    MDR report key: 2901619 · Received January 3, 2013

    Report

    Report Number
    2249697-2013-90007
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 13, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT HAD REVISION SURGERY ON (B)(6) 2012 DUE TO CYST AND POSSIBLE METALLOSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2846 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 8 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MJE79E

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention