BEUDAMED
    FDA Adverse Event Injury Summary report: N

    9/10 ULTAMET 28MM HEADS +0

    MDR report key: 10680663 · Received October 14, 2020

    Report

    Report Number
    1818910-2020-22316
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    September 30, 2020
    Report Date
    September 29, 2020
    Manufacturer
    DEPUY INTERNATIONAL LTD - 8010379
    Product Code
    JDI
    PMA / PMN Number
    K871867
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). 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 : PER WI-3430 IT HAS BEEN DETERMINED THAT A DHR REVIEW IS NOT REQUIRED.

    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.

    Description of Event or Problem · 1

    THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2007 VIA THA FOR THE PATIENT¿S RIGHT HIP JOINT. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO ARMD WHICH WAS CAUSED BY TRUNIONOSIS AND THE LOOSENING OF THE CUP. THERE WAS BONE DEFECT AT THE PATIENT¿S ACETABULAR. THE SURGEON RECONSTRUCTED THE ACETABULAR VIA IBG (IMPACTION BONE GRAFT) WITH MESH. THE EXPLANTED CUP WAS MANUFACTURED BY KYOCERA. IT WAS DIFFICULT TO REMOVE THE STEM, THE SURGEON COULD REMOVE THE STEM AND RECONSTRUCTED VIA IBG. NEW IMPLANTED STEM AND CUP WERE MANUFACTURED BY STRYKER. THE SURGERY WAS COMPLETED, AND IT WAS UNKNOWN WHETHER THERE WAS ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1142066 9/10 ULTAMET 28MM HEADS +0 SMALL TAPER (9/10) FEMORAL HEADS : HIP METAL FEMORAL HEADS JDI DEPUY INTERNATIONAL LTD - 8010379

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention AML A PLUS 10.0 MM| PINN-A BANTAM ACET CUP 40MM| PINNACLE MTL INS NEUT28IDX46OD