BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE/ABG II HIP

    MDR report key: 2801406 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01880
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    June 1, 2012
    Report Date
    September 25, 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
    MS, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. AT THIS TIME, THE PATIENT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER 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 HAVING A BURNING PAIN IN THE RIGHT HIP AT THE SITE OF THE IMPLANT SINCE (B)(6) 2012. IN (B)(6) 2012, SHE WAS DIAGNOSED AS HAVING INFLAMMATION IN THE RIGHT HIP. SHE RECEIVED A STEROID SHOT, A PRESCRIPTION FOR MOBIC WHICH SHE TAKES FOR INFLAMMATION AND PAIN, AND HAD 4 WEEKS OF PHYSICAL THERAPY. THE PATIENT STATES THAT THESE THERAPIES HAVE HELPED SOMEWHAT TO RELIEVE THE PAIN AND SWELLING. SHE WAS TOLD THAT HER CHROMIUM LEVEL AND COBALT LEVELS ARE ELEVATED. SHE HAS SEEN BOTH HER SURGEON AND PRIMARY CARE PHYSICIANS. RECENT X-RAYS INDICATED THAT THE HIP IS STILL INTACT. THE PATIENT STATES THAT HER SURGEON WILL MONITOR HER CONDITION WITH REPEAT TESTING EVERY 6 MONTHS. THE PATIENT STATES THAT SHE IS VERY ACTIVE AND EXERCISES REGULARLY 1 HOUR, 3 TIMES A WEEK.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other