BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERASUL ALPHA INSERT NEUTRAL II/28

    MDR report key: 3934625 · Received June 26, 2014

    Report

    Report Number
    9613350-2014-03671
    Event Type
    Injury
    Date Received
    June 26, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ZIMMER GMBH
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AT THE TIME OF THIS REPORT, THE AFFECTED DEVICE HAVE NOT BEEN RECEIVED. ONLY THE SURGICAL REPORT OF THE REVISION SURGERY WAS PROVIDED TOGETHER WITH THE PRODUCT LABELS. THE LOT NUMBERS WERE RECEIVED FOR THE DEVICES, AND THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. ONCE THE PRODUCTS ARE RECEIVED AN INVESTIGATED AND THE RESULT OF THE INVESTIGATION HAS BEEN MADE AVAILABLE, AN UPDATED REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2004, THE PT WAS IMPLANTED WITH A CERASUL ALPHA INSERT NEUTRAL, ON HER RIGHT HIP. 10 YEARS LATER, ON (B)(6) 2014, THE INLAY "SPONTANEOUSLY BROKE". THE PT HAD TO UNDERGO REVISION SURGERY ON (B)(6) 2014, DUE TO A BROKEN CERASUL ALPHA INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372980 CERASUL ALPHA INSERT NEUTRAL II/28 CERASUL ALPHA INSERT NEUTRAL II/28 KWA ZIMMER GMBH 2201089

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R