BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTAMET MTL INS NEUT 36MM 52OD

    MDR report key: 3103101 · Received May 9, 2013

    Report

    Report Number
    1818910-2013-16852
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. UPDATED REPORTING INDICATES NO PSEUDO-TUMOR WAS FOUND INTRA-OPERATIVELY. A SEARCH OF THE COMPLAINTS DATABASES FOUND TWO OTHER REPORT AGAINST THE 2482263 LOT CODE. PREVIOUS REVIEW OF DEVICE HISTORY RECORDS FOUND NO RELATED DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. NO OTHER REPORTS WERE FOUND AGAINST THE REPORTED 2563164 LOT CODE. ADDITIONAL INVESTIGATIONAL INPUTS AND EVENT INFORMATION WAS REQUESTED BUT NOT PROVIDED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO SOFT TISSUE REACTION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204276 ULTAMET MTL INS NEUT 36MM 52OD METAL ACETABULAR INSERT KWA 8010379 DEPUY INTL., LTD. 2563164

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention