BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 9315796 · Received November 13, 2019

    Report

    Report Number
    1818910-2019-112686
    Event Type
    Injury
    Date Received
    November 13, 2019
    Date of Event
    September 29, 2003
    Report Date
    October 17, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KXA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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 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, ""EDGE LOADING IN THIRD GENERATION ALUMINA CERAMIC-ON-CERAMIC BEARINGS"" WRITTEN BY WILLIAM L. WALTER, MBBS, GERARD M. INSLEY, PHD, WILLIAM K. WALTER, MBBS, AND MICHAEL A. TUKE, HNC, ME PUBLISHED BY THE JOURNAL OF ARTHROPLASTY VOL. 19 NO. 4 2004 ACCEPTED BY PUBLISHER 29 SEPTEMBER 2003 WAS REVIEWED. THE ARTICLE'S PURPOSE IS TO REPORT ON RESULTS OF A TOTAL OF 16 CASES OF RETRIEVED ALUMINA CERAMIC-ON-CERAMIC BEARINGS WITH THE GOAL OF CHARACTERIZING THE MECHANISM OF STRIP WEAR FORMATION TO UNDERSTAND HOW THIS WEAR OCCURS IN AN EFFORT TO PREVENT STRIPE WEAR BY MODIFYING SURGICAL TECHNIQUE OR IMPLANT DESIGN. IT IS NOTED THAT THE DEPUY SROM STEM IS UTILIZED IN 4 CASES IN CONJUNCTION WITH NON-DEPUY ACETABULAR COMPONENTS AND ALL CASES WERE REVISED. AS THE ACETABULAR COMPONENTS WERE NON-DEPUY THE BEARING SURFACES ARE NOTED AS NON-DEPUY. EACH CASE IS CAPTURED INDIVIDUALLY ON LINKED COMPLAINTS." THIS COMPLAINT CAPTURES CASE C4 A (B)(6) FEMALE WITH WHO WAS IMPLANTED WITH SROM STEM IN CONJUNCTION WITH NON-DEPUY ACETABULAR COMPONENTS AND REVISED FOR PERIPROSTHETIC FRACTURE OF THE FEMUR (SPECIFIC ANATOMICAL LOCATION NOT PROVIDED) WITH NO INDICATION OF WHICH PRODUCTS WERE EXPLANTED NOR THE SPECIFIC INTERVENTION (IF ANY) TO TREAT THE FRACTURE OTHER THAN THE CLASSIFICATION AS THE REVISION REASON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1111067 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KXA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention