BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 36 +5

    MDR report key: 3242402 · Received July 23, 2013

    Report

    Report Number
    1818910-2013-21889
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    April 1, 2010
    Report Date
    June 28, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE LOT CODES REQUIRED WERE NOT PROVIDED. PER THE INITIAL REPORTING BY THE DEPUY CLINICAL TEAM, 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 DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY 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

    CLINICAL REPORT STATES THE PATIENT HAD AN INCISION, DRAINAGE AND DEBRIDEMENT WITH LINER AND HEAD EXCHANGE FOR INFECTION 43 DAYS AFTER PRIMARY THA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343384 ASPHERE M SPEC 12/14 36 +5 HEAD KWA 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention