BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN RIGHT HIP NECK

    MDR report key: 2922565 · Received January 15, 2013

    Report

    Report Number
    9616680-2013-90131
    Event Type
    Injury
    Date Received
    January 15, 2013
    Date of Event
    January 1, 2011
    Report Date
    December 26, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS REPORTED THROUGH AN ATTORNEY, AS A RESULT OF A LEGAL CLAIM. DUE TO THE ONGOING LITIGATION, NO ADD'L INFO IS AVAILABLE AT THIS TIME. IF ADD'L INFO IS REC'D, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. THE REASON FOR THE SERIALIZATION STARTING WITH 90XXX IS TO PROVIDE CLARIFICATION FOLLOWING A CHANGE IN STRYKER'S ELECTRONIC COMPLAINT SYSTEMS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAS HAD IMPLANTS IN BOTH HIPS BUT SHE IS NOT SURE IF THE LEFT HIP IS A STRYKER OR NOT. THE PT STATES THAT SHE REC'D NOTIFICATION ABOUT THE RECALL FOR THE RIGHT HIP. THE LEFT HIP IS ASYMPTOMATIC BUT THE RIGHT HIP IS EXPERIENCING PAIN. THE PT STATES THAT SHE IS SCHEDULED FOR BLOOD TESTS AND AN MRI FOR THE RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22257 UNKNOWN RIGHT HIP NECK IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other