BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT REJUVENATE/ABG II HIP

    MDR report key: 2801402 · Received October 17, 2012

    Report

    Report Number
    2249697-2012-01911
    Event Type
    Injury
    Date Received
    October 17, 2012
    Date of Event
    September 1, 2011
    Report Date
    October 1, 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
    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 HER RIGHT HIP ACHES BADLY GIVING HER A PRONOUNCED LIMP. SHE STATES THAT SINE (B)(6) 2012, HER HIP IS ALWAYS PAINFUL AND WARM TO THE TOUCH. THE PATIENT HAD A DOCTORS APPOINTMENT ON (B)(6) 2012. THE PATIENT IS SCHEDULED TO COMPLETE BLOOD WORK AND AN MRI ON (B)(6) 2012. THE DOCTOR HAS STATED THAT HE SUSPECTS SHE WILL NEED A REVISION BUT IT CANNOT BE CONFIRMED UNTIL THE RESULTS OF HER TEST ARE IN.

    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 61 YR Other