BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY 32 +4 ENDURON LINER

    MDR report key: 2970796 · Received February 20, 2013

    Report

    Report Number
    1818910-2013-02256
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    October 15, 2012
    Report Date
    January 24, 2013
    Manufacturer
    DEPUY WARSAW
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS AND X-RAYS WERE PROVIDED AND REVIEWED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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

    THE PATIENT WAS REVISED BECAUSE OF A FRACTURED HIP STEM. (B)(4) 2013 - MEDICAL RECORDS RECEIVED. RECORDS INDICATE POLYWEAR WAS FOUND UPON REVISION. THE LINER WAS ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74859 UNKNOWN DEPUY 32 +4 ENDURON LINER LINER LPH DEPUY WARSAW UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention