BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND SCREW LOCK D4.5X30MM

    MDR report key: 3324478 · Received September 4, 2013

    Report

    Report Number
    1818910-2013-26080
    Event Type
    Injury
    Date Received
    September 4, 2013
    Date of Event
    August 20, 2013
    Report Date
    August 20, 2013
    Manufacturer
    3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST
    Product Code
    HSD
    PMA / PMN Number
    PK062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUP WAS THE ONLY PRODUCT RETURNED; THE REMAINING REPORTED PRODUCTS WERE NOT RETURNED. EXAMINATION OF THE RETURNED CUP BY A DEPUY FRANCE SUPPLIER CONFIRMED THE POLY WEAR. 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. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX D. NO ADDITIONAL INFORMATION OBTAINED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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 LOOSENING OF THE METAGLENE AND SEVERE POLY WEAR. OSTEOLYSIS WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439110 DXTEND SCREW LOCK D4.5X30MM SCREW HSD 3003895575 DEPUY FRANCE S.A.S.-SAINT PRIEST 2611236

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Required Intervention