BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND METAGLENE

    MDR report key: 2238776 · Received August 17, 2011

    Report

    Report Number
    1818910-2011-14405
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 18, 2011
    Manufacturer
    DEPUY FRANCE, S.A.
    Product Code
    HSD
    PMA / PMN Number
    K062250
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EXAMINATION OF THE RETURNED PRODUCTS BY A DEPUY FRANCE SUPPLIER CONFIRMED THE COMPLAINT. ALTHOUGH THE EXACT ROOT CAUSE COULD NOT BE DETERMINED, A HYPOTHESIS IS A CLINICAL PROBLEM (OSSEOUS PRODUCT, PROSTHETICS CONFLICT). A DEPUY FRANCE SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS FOR THE METAGLENE AND THE CUP AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. THE LOT NUMBER FOR THE GLENOSPHERE AND THE PART AND LOT NUMBER FOR THE SCREW WERE NOT PROVIDED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR THE PROVIDED METAGLENE AND CUP PART AND LOT NUMBER COMBINATIONS. BASED ON THE INABILITY TO DETERMINE A 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

    THE PT WAS REVISED BECAUSE OF LOOSE METAGLENE ADN BROKEN LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND METAGLENE 87 HSD; 87 KWS HSD DEPUY FRANCE, S.A. N 5008214

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention