BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRX +4 NEUT 36IDX52OD

    MDR report key: 2943851 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-11901
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK072963
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. PER THE REPORTING BY THE DEPUY CLINICAL TEAM; ONLY PATIENT DEMOGRAPHICS ARE 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

    CLINICAL REPORT STATES THAT THE PATIENT HAS SUFFERED DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47867 ALTRX +4 NEUT 36IDX52OD LINER KWA DEPUY ORTHOPAEDICS, INC. 154830

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR