BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP STEM

    MDR report key: 2915544 · Received January 10, 2013

    Report

    Report Number
    2249697-2013-90103
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    November 1, 2011
    Report Date
    December 20, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    KWY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH (B)(4) TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT IS REPORTED PT STATES THAT HER HIP DISLOCATED FOR A SECOND TIME. PT HAD SURGERY TO REPAIR DISLOCATION IN (B)(6) 2011. PT STATES THAT SHE IS IN EXCRUCIATING PAIN ALL THE TIME. PT HAS LIMITED MOBILITY AND MUST USE A WALKER OR WHEELCHAIR TO GET AROUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15160 UNKNOWN LEFT HIP STEM IMPLANT KWY STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other