BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX58OD

    MDR report key: 3021509 · Received March 26, 2013

    Report

    Report Number
    1818910-2013-14479
    Event Type
    Injury
    Date Received
    March 26, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORD FOR THE PROVIDED PRODUCT/LOT COMBINATION DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. REVIEW OF THE DEVICE HISTORY RECORD AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE FEMORAL HEAD AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. PER THE INITIAL REPORTING, NO ADDITIONAL INFORMATION IS AVAILABLE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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

    PATIENT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124536 PINNACLE MTL INS NEUT36IDX58OD ACETABULAR LINER KWA 8010379 DEPUY INTL., LTD. 1835668

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention