BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 28 +12 BLK

    MDR report key: 9521498 · Received December 26, 2019

    Report

    Report Number
    1818910-2019-124700
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    December 5, 2019
    Report Date
    December 5, 2019
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    UDI-DI
    10603295033127
    PMA / PMN Number
    K883460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    PRODUCT COMPLAINT # (B)(4). 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, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HIP BALL WAS DISLOCATED FROM CONSTRAINED LINER. LINER WAS DEEMED TO BE DAMAGED FROM SKIRT ON HIP BALL CAUSED POLY FIN BREAKAGE. BALL WAS NO LONGER CONSTRAINED BY LOCKING MECHANISM. DOI: (B)(6) 2018; DOR: (B)(6) 2019; LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1316346 ARTICUL/EZE BALL 28 +12 BLK ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY INTERNATIONAL LTD - 8010379 1365-14-000 D18040705 10603295033127

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention