BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMPLEX P FULL DOSE 1 PACK

    MDR report key: 2680182 · Received July 30, 2012

    Report

    Report Number
    9610726-2012-00256
    Event Type
    Injury
    Date Received
    July 30, 2012
    Date of Event
    July 14, 2012
    Report Date
    July 16, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    N17004
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT/EVENT AS MFR #9610726-212-00255

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: "CEMENT SET UP IN 8 MIN. THE CEMENT WAS OPENED AT THE BEGINNING OF THE CASE, AND THE ROOM WAS AT 73 DEGREES. THERE WAS LSO SOME HUMIDITY IN THE ROOM. CEMENT SET UP BEFORE WE COULD IMPLANT THE STEM AND CENTRALIZER. WE THEN WENT AND PRESS FIT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P FULL DOSE 1 PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA RCT036

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other