BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT 54OD X 36 ID

    MDR report key: 1895121 · Received November 5, 2010

    Report

    Report Number
    1818910-2010-07799
    Event Type
    Injury
    Date Received
    November 5, 2010
    Report Date
    October 7, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    FOLLOWING INVESTIGATION BY BIOENGINEERING, NOTIFICATION WAS RECEIVED THAT: PRODUCT HAS BEEN RECEIVED AND WILL BE INVESTIGATED AS PART OF THE 36MM MOM SERIES IN CONJUNCTION WITH AMLA PLUS. ROOT CAUSE: UNDETERMINED- CAPA (B)(4), NOTE THAT THE INITIAL DISLOCATION IN 2007 MAY HAVE CONTRIBUTED TO THE FAILURE. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE PRODUCT AND LOT COMBINATION. A REVIEW OF THE DEVICE HISTORY REPORT DID NOT REVEAL ANY ANOMALIES REGARDING THE REPORTED EVENT AGAINST THE PRODUCT AND LOT COMBINATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED EVENT. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED DUE TO DISLOCATION AND TISSUE DEGENERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT 54OD X 36 ID 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2296643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention