BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9336718 · Received November 18, 2019

    Report

    Report Number
    1818910-2019-114345
    Event Type
    Injury
    Date Received
    November 18, 2019
    Report Date
    October 28, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    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 WAS RECEIVED. ROOT CAUSE UNDETERMINED. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY 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

    THE LITERATURE ARTICLE ENTITLED, "BIPOLAR HIP REPLACEMENT IN SICKLE CELL DISEASE" WRITTEN BY B. K. S. SANJAY AND P. G. MOREAU PUBLISHED BY INTERNATIONAL ORTHOPAEDICS (SICOT) (1996) 20: 222 ¿ 226 ACCEPTED BY PUBLISHER 30 NOVEMBER 1995 WAS REVIEWED. THE ARTICLE'S PURPOSE: "PRESENT THE RESULTS, INCLUDING THE PROBLEMS OCCURRING DURING OPERATION AND IN THE POSTOPERATIVE PERIOD, OF UNCEMENTED BIPOLAR HIP REPLACEMENT CARRIED OUT IN 26 HIPS WITH ADVANCED AVASCULAR NECROSIS IN SICKLE CELL DISEASE." DATA IS PROVIDED IN A TABLE FOR THE 21 PATIENTS AND 26 HIPS. IT IS NOTED ONLY 3 PATIENTS RECEIVED DEPUY IMPLANTS AND ONLY 1 EXPERIENCED AN ADVERSE EVENT. NARRATIVE DESCRIPTION ALSO PROVIDES IDENTIFICATION OF CASE NUMBER FOR EACH ADVERSE EVENT. DEPUY PRODUCTS UTILIZED: AML STEM WITH BIPOLAR HEAD. ADVERSE EVENT: INTRA-OPERATIVE CALCAR FRACTURE TREATED WITH CERCLAGE WIRING. DEMOGRAPHICS: CASE # 9, (B)(6) YEAR OLD FEMALE WITH L THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128768 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM JDI DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention