BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP

    MDR report key: 2831159 · Received November 2, 2012

    Report

    Report Number
    2249697-2012-02220
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    November 16, 2011
    Report Date
    October 18, 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
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PT RECEIVED NOTIFICATION THAT HER RIGHT HIP IMPLANT WAS PART OF THE RECALL. SHE STATES THAT HER RIGHT HIP OFTEN STIFFENS UP AND SHE EXPERIENCES DISCOMFORT WHEN LYING ON HER RIGHT SIDE. THE PT IS SCHEDULED TO SEE HER PHYSICIAN IN LATE (B)(6) 2012 FOR EVAL.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other