BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP REJUVENATE/ ABGII STEM

    MDR report key: 2871899 · Received December 6, 2012

    Report

    Report Number
    2249697-2012-02581
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    May 12, 2020
    Report Date
    February 21, 2023
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    Z-2090-2012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PT WAS UNABLE TO IDENTIFY THE DEVICES IMPLANTED, HOWEVER, 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 WAS REPORTED THAT THE PT HAS PAIN AT THE THIP JOINT. ANYTIME THE PT MOVES IT HURTS. PT HAD CHECK-UP VISIT (B)(6) 2012. PT IS GOING TO HAVE AN ULTRA SOUND DONE, BECAUSE PT HAS A PACE MAKER AND CAN NOT HAVE A MRI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LEFT HIP REJUVENATE/ ABGII STEM IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Female Other