BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE/ABGII HIP

    MDR report key: 2821522 · Received October 24, 2012

    Report

    Report Number
    2249697-2012-02011
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    December 1, 2010
    Report Date
    October 5, 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
    NV, 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 SHE HAS BEEN HAVING PAIN AND DISCOMFORT IN HER LOWER BACK AND HIP FOR A LONG TIME. HER PAIN BEGAN APPROXIMATELY SEVEN MONTHS AFTER THE SURGERY IN 2010 AND CONTINUES TO BE PRESENT. SHE HAD AN MRI OF HER BACK IN (B)(6) 2012, WHICH INDICATED SOME ARTHRITIS IN HER BACK. THE PATIENT RECEIVED CORTISONE INJECTIONS IN HER SPINE FOR THE PAIN ON (B)(6) 2012. AT THAT TIME, THE DOCTOR STATED THAT HE BELIEVED THE SOURCE OF HER PAIN IS HER HIP AND NOT HER BACK. THE IMPLANT SITE IS VERY SORE TO THE TOUCH, BUT IS NOT SWOLLEN. SHE STATES THAT HER PAIN IS NOT DEBILITATING. SHE IS MORE AWARE OF THE PAIN WHEN SHE ATTEMPTS TO LAY ON IT. SOMETIMES SHE HAS TROUBLE SLEEPING BECAUSE OF THE DISCOMFORT. SHE STATES THAT APPLYING HEAT TO HER HIP HELPS THE PAIN. SHE ALSO STATES THAT SHE HAS HAD BOTH KNEES REPLACED. THE PATIENT IS SCHEDULING AN APPOINTMENT WITH HER SURGEON FOR BLOOD WORK AND FOLLOW-UP WITHIN THE NEXT TWO WEEKS WHEN SHE WILL BE IN (B)(6).

    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 64 YR Other