BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE/ABGII HIP

    MDR report key: 2821534 · Received October 24, 2012

    Report

    Report Number
    2249697-2012-01987
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    November 14, 2011
    Report Date
    October 3, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER 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 PT IS NOT CURRENTLY EXPERIENCING PAIN OR DISCOMFORT. PT STATES THAT HE RECEIVED A LETTER FROM DOCTOR ON (B)(6) 2012. PT ALSO STATES THAT HE HAD HIS BLOOD WORK DONE ON (B)(6) 2012. PT'S COBALT LEVEL WAS 4.8. PT UNSURE OF HIS CHROMIUM LEVEL. PT WAS ADVISED TO HAVE BLOOD WORK DONE IN SIX MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN RIGHT REJUVENATE/ABGII HIP IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other