BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ABG II MODULAR HIP STEM

    MDR report key: 2793983 · Received October 8, 2012

    Report

    Report Number
    9616680-2012-00858
    Event Type
    Injury
    Date Received
    October 8, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 18, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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 STATED HE HAS INCREASED COBALT LEVELS IN HIS BLOOD. HE IS EXPERIENCING "LITTLE SORENESS" ON THE SIDE OF HIS HIP. HE STATED THAT HE HAD RETAINED AN ATTORNEY. PT'S NAME WAS RECORDED FROM CALLER ID AS PT DID NOT WANT TO PROVIDE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ABG II MODULAR HIP STEM IMPLANT JDI STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other