BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NECK

    MDR report key: 2911062 · Received January 4, 2013

    Report

    Report Number
    9616680-2013-90021
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    August 1, 2009
    Report Date
    December 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICE 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 WAS REPORTED THAT THE PT IS EXPERIENCING PAIN IN HIP AREA. PT HAD BLOOD TEST AND MRI. PT IS SCHEDULED FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5183 UNKNOWN NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Other