BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE/ABG II HIP

    MDR report key: 2801404 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01909
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    November 29, 2010
    Report Date
    October 1, 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

    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 WAS REPORTED THAT THE PATIENT STATES THAT HE HAS STIFFNESS AND A PULLING PAIN IN THE FRONT OF THE RIGHT THIGH, THE GROIN, AND PAIN ON THE OUTER PART OF HIS WHICH EXTENDS INTO HIS BACK. HE ALSO HAS SOME SWELLING IN THE HIP AND THIGH. HE HAS A LOT OF PAIN WHEN HE STANDS FROM A SITTING POSITION. HE OCCASIONALLY FEELS SHARP PAIN IN THE GROIN AREA WHEN HE LIES DOWN. HE STATES THAT HE CAN'T WALK MORE THAN TWO BLOCKS WITHOUT INTENSE PAIN. IN (B)(6), HIS SURGEON ORDERED X-RAYS AND A CT SCAN. HE HAS HAD BLOOD DRAWN BUT IS NOT AWARE OF THE RESULTS. HIS DOCTOR DIAGNOSED THAT A REVISION SURGEON IS NECESSARY. HIS SURGERY IS SCHEDULED FOR (B)(6) 2012.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other