BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 0DEG 34MM

    MDR report key: 2831069 · Received November 2, 2012

    Report

    Report Number
    9616680-2012-00983
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    December 1, 2009
    Report Date
    October 9, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS CORK
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MFR. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD DEVICE OR ADDITIONAL INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PT / EVENT AS: MFR # 2249697-2012-02186.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT: PT IS EXPERIENCING "CLICKING AND POPPING" AND PAIN IN GROIN AREA. PT IS ALSO EXPERIENCING ADDITIONAL PAIN ON TOP OF THIGHS. PT IS REPORTING DIFFICULTY LIFTING LEG GOING UPSTAIRS FOR BOTH HIPS. PT IS ALSO EXPERIENCING DIFFICULTY STANDING TO GET OUT THE CAR AND HAS TO POP HIS HIPS BACK INTO PLACE. PT IS SCHEDULED FOR REVISION SURGERY ON (B)(6) 2012 FOR LEFT HIP. RIGHT HIP WILL BE REVISED APPROX 8 WEEKS AFTER LEFT HIP. ADDITIONAL INFO REPORTED VIA SALES REP: IT WAS REPORTED THAT, REJUVENATE REVISION. BLOOD SERUM ION LEVEL WAS ELEVATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 0DEG 34MM IMPLANT MEH STRYKER ORTHOPAEDICS CORK NA 25520701

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention