BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN LNR CON +4 10D 36IDX60OD

    MDR report key: 2941397 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-11798
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 7, 2013
    Report Date
    January 7, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWZ
    PMA / PMN Number
    PK043058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, 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 DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A PREVIOUS REVIEW OF THE HEAD'S DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE LINER'S PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. PER THE INITIAL REPORTING, THERE IS NO ADDITIONAL INFORMATION AVAILABLE. 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

    PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46494 PINN LNR CON +4 10D 36IDX60OD ACETABULAR LINER KWZ DEPUY ORTHOPAEDICS, INC. E13DF1

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention