BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX50OD

    MDR report key: 3072472 · Received April 23, 2013

    Report

    Report Number
    1818910-2013-15714
    Event Type
    Injury
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    DEPUY INTL., LTD./REG. #8010379
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A; REV. D. NO ADDITIONAL INFORMATION WAS OBTAINED. IT WAS REPORTED THAT THE SURGEON IMPLANTED THE LINER IN AN ANGLED POSITION. THE ROOT CAUSE IS ATTRIBUTED TO INADVERTENT USE ERROR. BASED ON THE INVESTIGATION, 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

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A MALPOSITIONED LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174348 PINNACLE MTL INS NEUT36IDX50OD ACETABULAR LINER KWA DEPUY INTL., LTD./REG. #8010379 3197798

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention