BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICULEZE M HEAD 36MM +8.5

    MDR report key: 7439424 · Received April 18, 2018

    Report

    Report Number
    1818910-2018-57581
    Event Type
    Injury
    Date Received
    April 18, 2018
    Date of Event
    January 18, 2017
    Report Date
    March 21, 2018
    Manufacturer
    DEPUY INTERNATIONAL LTD. 8010379
    Product Code
    JDI
    UDI-DI
    10603295033950
    PMA / PMN Number
    K980513
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH , A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    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

    INITIAL PROCEDURE, (B)(6) 2009 : TOTAL LEFT HIP REPLACEMENT. REVISION, (B)(6) 2010 : CONVERSION FROM METAL TO POLYETHYLENE IMPLANT. IT WAS REPORTED BY LEGAL THAT THE PATIENT EXPERIENCED TWO LEFT HIP DISLOCATION. ON (B)(6) 2017 A CLOSED REDUCTION WAS PERFORMED ON THE PATIENT, THE PHYSICIAN NOTED SOME CAPSULE CONTRACTURE LIMITING EXTERNAL ROTATION. IT WAS NOTED THAT ON (B)(6) 2011 THE PATIENT DID NOT HAVE ANY RECURRENCE OF DISLOCATION OR PAIN. DEVICES INVOLVED: 1217-22-060 ACETABULAR CUP, SZ 60, LOT EH5EG1000; 1219-36-460 PINNACLE MARATHON, LOT B64BL1000; 1365-53-000 METAL FEMORAL HEAD, LOT 2717713; 1217-20-500 CANCELLOUS BONE SCREW, 428157; 1217-20-500 CANCELLOUS BONE SCREW, 421818. RELATED COMPLAINT (B)(4) (PRIMARY SURGERY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282992 ARTICULEZE M HEAD 36MM +8.5 ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY INTERNATIONAL LTD. 8010379 2717713 10603295033950

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention