BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA FEM ADAPTER 5 DEGREE

    MDR report key: 3941907 · Received July 17, 2014

    Report

    Report Number
    1818910-2014-23668
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 10, 2014
    Report Date
    July 17, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    JWH
    PMA / PMN Number
    PK060515
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    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 CONFIRMED FRACTURE. THE DEVICE FRACTURE INITIATED DUE TO FATIGUE. NO MATERIAL DEFECTS WERE OBSERVED THAT COULD HAVE CONTRIBUTED TO THE FRACTURE INITIATION AND/OR PROPAGATION TO FAILURE. REVIEW OF THE DEVICE HISTORY RECORDS OF THE FRACTURED DEVICES 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 IS 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 RECEIVED KNEE TEP LEFT SIDE ON (B)(6) 2010. PAIN SINCE 2013. AN X-RAY SHOWED A BROKEN COMPONENT. REVISION ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418578 SIGMA FEM ADAPTER 5 DEGREE KNEE OTHER IMPLANT JWH DEPUY ORTHOPAEDICS, INC.1818910 EP2L31000

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other