BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARTICUL/EZE BALL 32 +13 BLK

    MDR report key: 13900530 · Received March 25, 2022

    Report

    Report Number
    1818910-2022-05413
    Event Type
    Injury
    Date Received
    March 25, 2022
    Date of Event
    March 4, 2022
    Report Date
    March 25, 2022
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    UDI-DI
    10603295033202
    PMA / PMN Number
    K883460
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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 · 0

    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. DEVICE HISTORY LOT ==> A MANUFACTURING RECORD EVALUATION (MRE), WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT CODE WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NO RECORDS PREVIOUS WERE AVAILABLE ON PATIENT¿S PREVIOUS SURGERY BUT SURGEON BELIEVES IT WAS APPROXIMATELY 2010. PATIENT REPORTS DISLOCATED HIP IN SEPARATE CITY THE PREVIOUS WEEKEND. THIS COMPLAINT WAS CREATED TO CAPTURE THE DISLOCATION THAT WAS MENTIONED IN THE EVENT DESCRIPTION UNDER (B)(4). DOI: UNKNOWN; AFFECTED SIDE: RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009274 ARTICUL/EZE BALL 32 +13 BLK ARTICULEZE HEAD (12/14 TAPER) : HIP METAL FEMORAL HEADS JDI DEPUY INTERNATIONAL LTD - 8010379 1365-24-000 10603295033202

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Required Intervention