BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX60OD

    MDR report key: 2251742 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18338
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    August 19, 2011
    Manufacturer
    DEPUY WARSAW
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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.

    Additional Manufacturer Narrative · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6) 2007, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP. PATIENT HAS SUSTAINED SIGNIFICANT EXPOSURE TO METAL DEBRIS AND METALLIC IONS. PATIENT HAS NOT YET BEEN REVISED. DOI: (B)(6) 2007 - DOR: UNK (UNKNOWN SIDE). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE 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.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: ON OR ABOUT (B)(6), 2007, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE HIP. PATIENT HAS SUSTAINED SIGNIFICANT EXPOSURE TO METAL DEBRIS AND METALLIC IONS. PATIENT HAS NOT YET BEEN REVISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT40IDX60OD HIP KWA DEPUY WARSAW 2387886

    Patients

    Seq Age Sex Outcome Treatment
    1