BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X30MM

    MDR report key: 2545175 · Received April 23, 2012

    Report

    Report Number
    1818910-2012-10176
    Event Type
    Injury
    Date Received
    April 23, 2012
    Date of Event
    March 30, 2012
    Report Date
    March 30, 2012
    Manufacturer
    DEPUY FRANCE
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A DEPUY FRANCE SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. ONE OF THE 30MM LOCKING SCREWS HAD TWO TABS BROKEN OFF. ALL PIECES WERE RETRIEVED FROM THE JOINT. THERE WAS ALSO A DISTAL HUMERAL FRACTURE BELOW THE STEM PRIOR TO THE START OF THE SURGERY. ALL IMPLANTS WERE FOUND TO BE LOOSE AS A RESULT OF THE INFECTION, WITH THE CEMENTED ONES BEING LOOSE AT THE CEMENT/BONE INTERFACE. COMPETITOR CEMENT WAS USED IN THE PRIMARY SURGERY. POLY WEAR WAS ALSO REPORTED. DOI APPROX 2007 - DOR (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND SCREW LOCK D4.5X30MM EXTREMITY IMPLANT HSD DEPUY FRANCE 2361514

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention