BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERSAL FEM SLV FUL POR 46MM

    MDR report key: 4101522 · Received September 19, 2014

    Report

    Report Number
    1818910-2014-28480
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    September 12, 2014
    Report Date
    December 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK063633
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICE DID NOT IDENTIFY AN PRODUCT FAILURE. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MANUFACTURING DEVIATIONS OR ANOMALIES. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A BROKEN FEMORAL ADAPTOR AND LOOSENING. THE FEMORAL ADAPTOR ON SROM FEMORAL COMPONENT BROKE AT THE SLEEVE TO FEMUR JUNCTION. LOOSENING OCCURED AT THE CEMENT/IMPLANT INTERFACE. CEMENT WAS MANUFACTURED BY A COMPETITOR. NOTE: X-RAYS WERE RECEIVED VIA EMAIL COMMUNICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584179 UNIVERSAL FEM SLV FUL POR 46MM KNEE OTHER IMPLANT KWA DEPUY ORTHOPAEDICS, INC. E5EFS1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention