BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN LEFT HIP REJUVENATE/ABGII NECK

    MDR report key: 3571849 · Received January 3, 2014

    Report

    Report Number
    9616680-2013-90213
    Event Type
    Injury
    Date Received
    January 3, 2014
    Date of Event
    January 1, 2012
    Report Date
    December 17, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT WAS CONFIRMED. A VOLUNTARY RECALL RA 2013-067 WAS INITIATED FOR ABGII AND REJUVENATE MODULAR STEMS AND NECKS DUE TO THE POTENTIAL RISKS ASSOCIATED WITH THESE DEVICES. THE REPORTED EVENT IS CONSIDERED TO BE UNDER THE SCOPE OF THIS RECALL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT IS EXPERIENCING OCCASIONAL PAIN SWELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3711 UNKNOWN LEFT HIP REJUVENATE/ABGII NECK IMPLANT MEH STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other