BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TROCHANTERIC GRIP W/ 2 CABLES

    MDR report key: 3243804 · Received July 23, 2013

    Report

    Report Number
    0002249697-2013-02413
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    HRS
    PMA / PMN Number
    K070170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION DUE TO HOSPITAL POLICY. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE PATIENT IS (B)(6) IN HEIGHT. AN EVENT REGARDING TISSUE IRRITATION INVOLVING A TROCHANTERIC GRIP WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: DEVICE HISTORY RECORDS FOR THE SPECIFIC LOT INDICATED THAT THE DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: A REVIEW OF THE COMPLAINT HISTORY DATABASE SHOWS THAT THERE HAVE BEEN NO SIMILAR REPORTED EVENTS FOR THE SUBJECT LOT CODE. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THERE WAS INSUFFICIENT INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SOFT TISSUE IRRITATION, PLATE WAS REMOVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SOFT TISSUE IRRITATION, PLATE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343053 TROCHANTERIC GRIP W/ 2 CABLES IMPLANT HRS STRYKER ORTHOPAEDICS-MAHWAH G3070305

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R