BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +15.5

    MDR report key: 3140374 · Received May 31, 2013

    Report

    Report Number
    1818910-2013-06544
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    November 12, 2012
    Report Date
    May 8, 2013
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    LPH
    PMA / PMN Number
    K120599
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE PROVIDED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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 ONGOING INFECTION. UPDATE: (B)(6) 2013 - PATIENTS MEDICAL RECORDS WERE RECEIVED. RECORDS INDICATE THE PATIENT WAS REVISED ON (B)(6) 2012, TO ADDRESS BURSITIS AND WOUND DRAINAGE. UPON REVISION FRETTING AND CORROSION WAS NOTED ON TRUNNINON OF THE FEMORAL COMPONENT. THE METAL INSERT WAS REMOVED. THE PATIENT WAS REIMPLANTED ON (B)(6) 2012, AT WHICH TIME THE FEMORAL HEAD WAS REMOVED. RECORDS INDICATE THERE WAS OSTEOLYSIS NOTED IN THE HIP ALONG WITH GRAYISH GRUMOUS/CASEATING TYPE MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241858 ARTICULEZE M HEAD 36MM +15.5 FEMORAL HEAD LPH DEPUY INTERNATIONAL 1823535

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention