BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7

    MDR report key: 2901605 · Received January 3, 2013

    Report

    Report Number
    2249697-2012-02830
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 10, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K071082
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON REVISED PT'S RIGHT REJUVENATE HIP, DUE TO PAIN AND ELEVATED COBALT LEVELS. REPLACED WITH EXETER SYSTEM. SALES REP WILL PROVIDE X-RAYS, PRE AND POST OP NOTES, LAB REPORT AND IMPLANT SHEETS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2319 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 7 IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA MJRRT1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Other| R