BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 8663990 · Received June 3, 2019

    Report

    Report Number
    1818910-2019-95098
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    January 1, 2019
    Report Date
    May 15, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY ==> NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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

    LITERATURE ARTICLE ENTITLED: "OUTCOMES OF A METAL-ON-METAL TOTAL HIP REPLACEMENT SYSTEM". THE STUDY ANALYZED THE OUTCOMES OF METAL ON METAL THR SYSTEMS INVOLVING THE CORAIL STEM, PINNACLE CUP, ULTRAMET LINER, AND ARTICULEZE FEMORAL HEAD. 578 UNCEMENTED HIPS WERE FOLLOWED IN THE STUDY. 39 HIPS FROM 38 PATIENTS WERE REVISED WITHIN A MEAN TIME OF 3.5 YEARS. THEY WERE IDENTIFIED BY AGE/GENDER. PATIENT #38 IS (B)(6) YEAR OLD MALE REVISED FOR ADVERSE REACTION TO METAL DEBRIS. ELEVATED CO/CR BLOOD METAL IONS WERE NOTED PRIOR TO REVISION. THE STEM , CUP, HEAD AND LINER WERE REVISED. INTRAOPERATIVE FINDINGS INCLUDE METALLOSIS AND MISPOSITIONED CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457061 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention