BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP

    MDR report key: 2821381 · Received October 23, 2012

    Report

    Report Number
    2249697-2012-01977
    Event Type
    Injury
    Date Received
    October 23, 2012
    Date of Event
    May 15, 2012
    Report Date
    October 2, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, BUT BELIEVES THEM TO BE EITHER REJUVENATE OR ABG II. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT HAS BEEN IN AGONY SINCE SHORTLY AFTER HIS IMPLANT OPERATION IN (B)(6) 2012. HE HAS HAD REPEATED VISITS WITH HIS SURGEON AND HAS STATED THAT THE IMPLANT NEVER FELT RIGHT. HIS PAIN WAS NOT RELIEVED BY MEDICATION. HE HAD REVISION SURGERY ON (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other