BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11

    MDR report key: 2120068 · Received May 26, 2011

    Report

    Report Number
    2249697-2011-00762
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 1, 2011
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K071082
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, "SURGEON WAS DOING A BIPOLAR ON A LARGE MALE. BONE STOCK WAS GOOD. SURGEON REFERRED TO BONE QUALITY AS 'ROCK SOLID.' SURGEON REAMED SEQUENTIALLY USING REJUVENATE REAMERS. SEQUENTIALLY BROACHED UP TO A SIZE 11 BROACH. BROACH WAS FULLY SEATED. THE BROACH WAS REMOVED AND STEM WAS IMPLANTED. THE STEM SUBSIDED 2-4MM FROM WHERE THE BROACH WAS SEATED. THE STEM WAS REMOVED TO INVESTIGATE FOR A FRACTURE. NO FRACTURE WAS FOUND AND STEM WAS RE-IMPLANTED AND CALCAR PLANED. SURGEON IS CONCERNED ABOUT THE STEMS AND BROACHES BEING CONSISTENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REJUVENATE STRGHT PRFIT TMZF MOD STEM SIZE 11 IMPLANT JDI STRYKER ORTHOPAEDICS MAHWAH NA 7KKMMD

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention