BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NECK

    MDR report key: 2871937 · Received December 6, 2012

    Report

    Report Number
    9616680-2012-01331
    Event Type
    Injury
    Date Received
    December 6, 2012
    Date of Event
    March 17, 2009
    Report Date
    November 14, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    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 SUBMITTED ON A SUPPLEMENTAL REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT IS REPORTED, PT RECEIVED A LETTER REGARDING THE RECALL. THE PT REPORTS THAT THEY OCCASIONALLY HAVE AN ACHING LATERAL PAIN IN THE LEG AND EXTENDS INTO THE LOWER PART OF THE BUTTOCKS. THE PT SOMETIMES HAS TROUBLE GOING UP STEPS AND CAN NOT PUT FULL WEIGHT ON THE LEG DUE TO WEAKNESS IN THE RIGHT HIP AND THIGH. THE PT HAD BILATERAL HIP IMPLANTS. THE LEFT HIP IS NOT PART OF THE RECALL AND IS ASYMPTOMATIC. THE PT IS SCHEDULED FOR AN MRI AND BLOOD LABS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other| R