BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LRG TAP PRI MOD NCK 8DEG 34MM

    MDR report key: 2832996 · Received October 30, 2012

    Report

    Report Number
    9616680-2012-00965
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 5, 2012
    Manufacturer
    STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI
    Product Code
    MEH
    PMA / PMN Number
    K092561
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVAL OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PT AND WAS NOT RETURNED TO THE MFR. ADD¿L INFO PERTAINING TO THE DEVICE REFERENCED IN THIS REPORT (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. SHOULD ADD¿L INFO BECOME AVAILABLE, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. THIS IS THE SAME PATIENT/EVENT AS: MFR NUMBER: 2249697-2012-02120.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COMPLAINED OF PAIN IN RIGHT HIP. MRI SHOWED FLUID BUILD UP AND EXTENSIVE TISSUE DAMAGE. SURGEON NOTICED EXCESSIVE FRETTING AT THE HEAD NECK JUNCTION. REPLACED WITH A RESTORATION MODULAR CONE CONICAL HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LRG TAP PRI MOD NCK 8DEG 34MM IMPLANT MEH STRYKER IRELAND, LTD. OSTEONICS (ORTHOPAEDICS DIVI UNK 32301502

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention