BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 52OD

    MDR report key: 3012086 · Received March 20, 2013

    Report

    Report Number
    1818910-2013-14110
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 14, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO SIMILAR REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF PROVIDED PATIENT X-RAY BY DEPUY COMMERCIALIZED PRODUCT DEVELOPMENT FOUND NO ABNORMALITIES WERE DETERMINED FROM THE REVIEW. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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.

    Description of Event or Problem · 1

    REVISED LINER AND THE HEAD AND WERE THEN DISCARDED. PATIENT HAD PAIN AND STIFFNESS WITH SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    115491 ULTAMET MTL INS NEUT 36MM 52OD METAL LINSERT KWA 8010379 DEPUY INTL., LTD. 1147534

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention