BEUDAMED
    FDA Adverse Event Other Summary report: N

    FOUNDATION HIP

    MDR report key: 2674284 · Received July 25, 2012

    Report

    Report Number
    1644408-2012-00380
    Event Type
    Other
    Date Received
    July 25, 2012
    Date of Event
    July 9, 2012
    Report Date
    July 9, 2012
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS DUE TO THE PATIENT DEVELOPING AN INFECTION. THE IMPLANTS THAT WERE REMOVED ON (B)(6) 2012 DURING THE INITIAL SURGERY WERE FROM AN UNKNOWN MANUFACTURER AND NOT DJO SURGICAL PRODUCTS. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS NOT RETURNED TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS AND PRODUCT COMPLAINT REPORT HISTORY WERE NOT PERFORMED DUE TO LACK OF INFORMATION PROVIDED AND THE IMPLANTS BEING FROM ANOTHER MANUFACTURER. THE ROOT CAUSE FOR THIS INVESTIGATION IS THAT THE PATIENT DEVELOPED AN INFECTION AND THE SURGEON'S PROCESS TO ALLEVIATE THE INFECTION. THERE WAS NO DJO SURGICAL PRODUCT INVOLVED THAT CONTRIBUTED TO THE OCCURRENCE OF THIS EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY - THIS IS THE PT'S SECOND REVISION SURGERY. THE PT WAS REVISED DUE TO INFECTION, AND A SIZE 45 BIPOLAR SHELL WAS REMOVED. THE SURGEON THEN IMPLANTED A SIZE 8MM FOUNDATION HEAD 450 SERIES HIP STEM AND ANTIBIOTIC SPACER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOUNDATION HIP MODULAR BIPOLAR SHELL KWB ENCORE MEDICAL, L.P. 990B1066

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention