BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT DUOFIX TAP SZ4 STD OFF

    MDR report key: 3010363 · Received March 19, 2013

    Report

    Report Number
    1818910-2013-14037
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS
    Product Code
    LPH
    PMA / PMN Number
    PK011489
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. REVIEW PROVIDED PATIENT X-RAYS CONFIRM THE REPORTED FRACTURE. X-RAY IMAGE QUALITY IS POOR DUE TO APPARENT DIGITAL CAMERA PHOTOGRAPH, SHOWING REFLECTION OF ROOM LIGHTING. THE X-RAY IMAGE DISPLAYS THE APPEARANCE OF A FRACTURED MEDIAL CALCAR ON THE RIGHT HIP. THE DATE OF THE X-RAY IS UNKNOWN. NO DEVICES WERE RETURNED FOR REVIEW. THE REASON FOR THE STATED PERIPROSTHETIC FRACTURE IS UNKNOWN. THE EXACT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. LIMITED PATIENT DEMOGRAPHICS MADE AVAILABLE IN THAT THE PATIENT IS A (B)(6) YEAR OLD WITH UNKNOWN GENDER, WEIGHT, HEIGHT, OR ACTIVITY LEVEL. X-RAYS INDICATE THE PATIENT IS OF LARGER STATURE. BMI WAS NOT PROVIDED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION SINCE ITS RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    HIP REVISION FOR PERIPROSTHETIC FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113870 SUMMIT DUOFIX TAP SZ4 STD OFF HIP STEM LPH DEPUY ORTHOPAEDICS 289904

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention