BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M 28MM 8.5

    MDR report key: 3926389 · Received July 10, 2014

    Report

    Report Number
    1818910-2014-23108
    Event Type
    Injury
    Date Received
    July 10, 2014
    Date of Event
    October 10, 2005
    Report Date
    June 12, 2014
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    LPH
    PMA / PMN Number
    PK843909
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS RECEIVED FOR ANOTHER COMPLAINT AND ANOTHER REVISION WAS DISCOVERED. THE PATIENT WAS IMPLANTED ON (B)(6) 2005 AND REVISED ON (B)(6) 2005 FOR RECURRENT DISLOCATIONS. ONLY THE FEMORAL HEAD WAS REVISED, BUT BOTH THE FEMORAL HEAD AND LINER ARE BEING REPORTED. THE LINER HAS ALREADY BEEN REPORTED ON (B)(4). DOI: (B)(6) 2005 DOR: (B)(6) 2005 (FEMORAL HEAD)-RIGHT HIP THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION. MEDICAL RECORDS WERE OBTAINED AND REVIEWED BY A MEDICAL PROFESSIONAL. FROM A MEDICAL PERSPECTIVE, BASED ON THE INFORMATION AVAILABLE, THE COMPLAINT IS NOT PRODUCT RELATED. 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 ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED FOR ANOTHER COMPLAINT AND ANOTHER REVISION WAS DISCOVERED. THE PATIENT WAS IMPLANTED ON (B)(6) 2005 FOR RECURRENT DISLOCATIONS. ONLY THE FEMORAL HEAD WAS REVISED, BUT BOTH THE FEMORAL HEAD AND LINER ARE BEING REPORTED. THE LINER HAS ALREADY BEEN REPORTED ON (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404390 ARTICULEZE M 28MM 8.5 HIP FEMORAL HEAD LPH DEPUY INTERNATIONAL LTD. 8010379 XPD16

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention