BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL HEAD

    MDR report key: 9199092 · Received October 16, 2019

    Report

    Report Number
    1818910-2019-108539
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    November 10, 2017
    Report Date
    September 25, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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. (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)].

    Description of Event or Problem · 1

    "LITERATURE ARTICLE ENTITLED, ¿CEMENTED TOTAL HIP REPLACEMENT IN PATIENTS UNDER 55 YEARS GOOD RESULTS IN 104 HIPS FOLLOWED UP FOR 22 YEARS¿ BY MANISH KIRAN, ET AL, PUBLISHED BY ACTA ORTHOPEDICA (2018), VOL. 89, NO. 2, PP. 152-155, WAS REVIEWED FOR MDR REPORTABILITY. THE AUTHORS USE THIS STUDY TO RETROSPECTIVELY DETERMINE THE IMPLANT SURVIVORSHIP AND FUNCTIONAL OUTCOMES OF 100 CEMENTED THAS IMPLANTED BETWEEN JANUARY 1990 AND DECEMBER 1995 USING THE CHARNLEY/OGEE (DEPUY) THA IN PATIENTS UNDER THE AGE OF 55. RADIOGRAPHS WERE TAKEN AT EVERY FOLLOW-UP. ALL THE RADIOGRAPHS WERE ANALYZED FOR SIGNS OF IMPLANT FAILURE, WEAR, LOOSENING, HETEROTOPIC OSSIFICATION, AND FRACTURES. RESULTS: 3 INSTANCES OF DISLOCATION, ONE REQUIRING REVISION. THE AUTHORS INDICATE THAT THE ¿MAJORITY¿ OF PATIENTS WERE PAIN FREE. 1 SUPERFICIAL INFECTION- NO TREATMENT DEFINED. 2 POSTOPERATIVE PERIPROSTHETIC FEMORAL FRACTURES- NO TREATMENT DEFINED. 1 HIP REVISED FOR ASEPTIC LOOSENING OF THE ACETABULAR CUP AT 15 YEARS. 1 HIP REVISED (2-STAGE) FOR DEEP INFECTION AT 13 YEARS. 1 REVISION FOR RECURRENT DISLOCATION AT 8 YEARS. RADIOGRAPHIC RESULTS: 14 ACETABULAR COMPONENTS AND 4 FEMORAL COMPONENTS. CONSIDERED ¿AT RISK¿ FOR LOOSENING, NO REVISIONS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992839 UNKNOWN HIP FEMORAL HEAD HIP FEMORAL HEAD KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention