BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP NECK

    MDR report key: 2912788 · Received January 8, 2013

    Report

    Report Number
    9616680-2013-90071
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    November 30, 2010
    Report Date
    December 19, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: PT HAS BEEN EXPERIENCING HIP PAIN SINCE THE ORIGINAL IMPLANT. THE PAIN IS CONSTANT AND DEBILITATING HAS DRASTICALLY AFFECTED HIS QUALITY OF LIFE. PT WAS UNHAPPY WITH THE RESPONSE FROM HIS PRIMARY SURGEON AND HAS BOUGHT OPINIONS FROM THREE OTHER ORTHOPAEDIC SURGEONS. A REVISION SURGERY WAS RECOMMENDED BY ONE OF THE REFERRING SURGEONS IN (B)(6) 2012. THE PT HAS NOT CONSENTED TO A REVISION. THE PT JUST LEARNED OF THE RECALL FROM THE PRIMARY SURGEON AND IS VERY UPSET. THE PT HAS CHANGED SURGEONS. PT RECENTLY HAD BLOOD TESTS AND IS SCHEDULED FOR A MARS MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9909 UNKNOWN RIGHT HIP NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other