BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL AUGMENT

    MDR report key: 10138612 · Received June 10, 2020

    Report

    Report Number
    1818910-2020-13607
    Event Type
    Injury
    Date Received
    June 10, 2020
    Date of Event
    March 28, 2019
    Report Date
    June 1, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, DEPUY SYNTHES JOINT RECONSTRUCTION, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. 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 REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    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).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED, "BREAKING BAD: A COMPARATIVE DESCRIPTIVE ANALYSIS OF PERIPROSTHETIC FRACTURES AROUND CEMENTED AND UNCEMENTED FEMORAL STEMS" WRITTEN BY CHRISTOPHER FENELON, MB BCH, MCH, MRCSI, EVELYN P. MURPHY, MB BCH, MCH, MRCSI, MUHAMMAD N. BAIG, MB BCH, MRCSI, CHM, STEPHEN R. KEARNS, MB BCH, MD, FRCSI, COLIN G. MURPHY, MB BCH, FRCSI, AND WILLIAM CURTIN, MB BCH, FRCSI PUBLISHED BY THE JOURNAL OF ARTHROPLASTY PUBLISHED ONLINE 28 MARCH 2019 WAS REVIEWED. THE ARTICLE'S PURPOSE TO REVIEW RADIOGRAPHS OF FEMORAL PERIPROSTHETIC FRACTURES (PPF)TO TRY IDENTIFY IF FRACTURE PATTERNS AROUND DIFFERING TYPES OF FEMORAL PROSTHESES EXISTED. DATA WAS COMPILED FROM 138 PATIENTS WHO UNDERWENT SURGERY FOR A PPF WITH MEAN AGE OF 78 YEARS. THE MAJORITY OF THESE PATIENTS PREVIOUSLY UNDERGONE A TOTAL HIP ARTHROPLASTY AND OTHERS RECEIVED HEMIARTHROPLASTY OR REVISION THA. TABLE 2 PROVIDES A LIST OF DEPUY AND NON-DEPUY FEMORAL STEMS WITH A NUMBER COUNT OF EITHER CEMENT OR NON-CEMENT FIXATIONS THAT WERE ASSOCIATED WITH PPFS THAT ACCOUNTED FOR ALL 138 PATIENTS. CEMENT MANUFACTURER IS NOT IDENTIFIED AND NO OTHER ADVERSE EVENTS ARE DISCUSSED WITHIN THE ARTICLE. OTHER COMPONENTS NOT IDENTIFIED OR DISCUSSED. FIGURES 1 AND 2 PROVIDE RADIOGRAPHIC IMAGES WITHOUT PRODUCT IDENTIFICATION DEPICTING PATTERNS OF PPFS. DEPUY PRODUCTS: CEMENTED CHARNLEY (QTY 26), CEMENTED C-STEM (QTY 1), UNCEMENTED CORAIL (QTY 30), UNCEMENTED SROM (QTY 1), AND UNCEMENTED SOLUTION (QTY 1). ADVERSE EVENT(S): PERIPROSTHETIC FRACTURE (TREATED BY REVISION OR ORIF).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604633 UNKNOWN HIP FEMORAL AUGMENT HIP FEMORAL AUGMENT KWY DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention