BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM +4 V40 TAPER VIT HEAD

    MDR report key: 2922164 · Received January 14, 2013

    Report

    Report Number
    9616680-2013-90117
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 15, 2012
    Report Date
    December 26, 2012
    Manufacturer
    STRYKER ORHTOPAEDICS CORK
    Product Code
    KWY
    PMA / PMN Number
    K993601
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE STERILIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, PT HEARD A POP SOUND, FELL AND WENT TO THE EMERGENCY ROOM. X-RAY SHOWED THE HEAD HAD DISASSOCIATED FROM THE HIP STEM. REVISION WAS PERFORMED AND IT WAS FOUND THAT THE TAPER ON THE HIP STEM HAD WORN SUCH THAT A NEW HEAD COULD NOT BE REPLACED. THE STEM WAS REMOVED AND A MOD. RESTO. STEM WAS PUT IN. THE SURGEON ELECTED TO CHANGE THE LINER AS WELL AS REMOVE THE BONE SCREW FROM THE CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    20022 32MM +4 V40 TAPER VIT HEAD IMPLANT KWY STRYKER ORHTOPAEDICS CORK NA 031225705501

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention