BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVELATION MICROMAX V2 HIP SYSTEM

    MDR report key: 6201496 · Received December 22, 2016

    Report

    Report Number
    1644408-2016-01042
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 30, 2016
    Report Date
    February 10, 2017
    Manufacturer
    ENCORE MEDICAL, L.P.
    Product Code
    KWA
    UDI-DI
    00888912080996
    PMA / PMN Number
    K083651
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REASON FOR THIS REVISION SURGERY WAS A HIP PERI-PROSTHETIC FRACTURE. THE IN-VIVO LENGTH OF PATIENT SERVICE FOR THE IMPLANT WAS 1.6 MONTHS. THERE IS NO INFORMATION IN THIS COMPLAINT ABOUT ANY PATIENT INJURIES, ACTIVITIES, OR ACCIDENTS THAT MAY HAVE CONTRIBUTED TO THE NEED FOR THIS REVISION SURGERY. THE HEALTHCARE PROFESSIONAL INDICATED THERE WAS A SERIOUS RISK TO THE PATIENT. THERE WAS NO DELAY IN SURGERY AND ANOTHER SUITABLE DEVICE WAS AVAILABLE FOR USE. THE REVISION SURGERY WAS COMPLETED AS INTENDED. THE DEVICE WAS DISPOSED OF AT THE HOSPITAL AND NOT MADE AVAILABLE TO DJO SURGICAL FOR EXAMINATION. A REVIEW OF THE DEVICE HISTORY RECORDS (DHRS) REVEALED NO DISCREPANCIES OR ISSUES WITH THE MANUFACTURING OF THIS PART. ALL CRITICAL DIMENSIONS AND SPECIFICATIONS IN EFFECT AT THE TIME THE PART WAS MANUFACTURED WERE MET. THE PRODUCT COMPLAINT REPORT HISTORY WAS REVIEWED AND NO TRENDS OR ON-GOING ISSUES WERE DEEMED AS PRESENT OR IN NEED OF REVIEW. THIS EVENT IS DEEMED AS NON-PRODUCT RELATED. THE PATIENT REPORTED NO FALL OR FORCE; THE COMPLAINT REPORTED A STRESS FRACTURE FROM THE IMPLANT. THE SCOPE OF THIS INVESTIGATION IS LIMITED WITHOUT HAVING THE PARTS AVAILABLE TO DJO SURGICAL FOR EVALUATION. OTHER CONDITIONS RELATING TO THIS EVENT COULD NOT BE DETERMINED WITH CONFIDENCE. INVENTORY CONTAINMENT IS NOT REQUIRED SINCE THERE ARE NO INDICATIONS OF A PRODUCT OR PROCESS ISSUE AFFECTING IMPLANT SAFETY OR EFFECTIVENESS.

    Description of Event or Problem · 1

    REVISION SURGERY - THE PATIENT CAME IN FOR THE 2 WEEK POST OP CHECK-UP, EVERYTHING WAS FINE, X-RAY LOOKED GREAT. THEY CAME BACK FOR THE 4 WEEK CHECK-UP AND REPORTED PAIN. AN X-RAY FOUND A FRACTURE. THE PATIENT REPORTED NO FALL OR FORCE. STRESS FRACTURE FROM IMPLANT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848507 REVELATION MICROMAX V2 HIP SYSTEM REVELATION MICROMAX, REDUCED NECK, SZ 15.0 RIGHT KWA ENCORE MEDICAL, L.P. 714G1038 00888912080996

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R