BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP NECK

    MDR report key: 2893464 · Received December 21, 2012

    Report

    Report Number
    9616680-2012-01491
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    August 8, 2011
    Report Date
    December 3, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    LZO
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 WAS REPORTED THAT THE PT IS SCHEDULED FOR REVISION SURGERY IN (B)(6) 2013. THE PT HAS BEEN EXPERIENCING PROBLEMS WITH HER HIP FOR A LONG TIME. ALSO, TUMORS HAVE BEEN FOUND IN HER HIP SO SURGEON HAS DECIDED TO REVISE. THE PT, PT IS EXPERIENCING PAIN, NUMBNESS AND BALANCE IS OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LEFT HIP NECK IMPLANT LZO STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other