BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DXTEND MOD EPI 1 ECC RIGHT HA

    MDR report key: 2016771 · Received March 10, 2011

    Report

    Report Number
    1818910-2011-03952
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    DEPUY FRANCE S.A.S. -SAINT PRIEST
    Product Code
    KWS
    PMA / PMN Number
    K071379
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A DEPUY FRANCE SUPPLIER REVIEWED THE DEVICE HISTORY RECORDS AND FOUND THE PRODUCTS CONFORMED TO THE REQUIRED SPECIFICATIONS AND FOUND NO MANUFACTURING DEVIATIONS OR ANOMALIES. DEPUY FRANCE REVIEWED THE STERILE CERTIFICATIONS FOR THE PRODUCT CODE / LOTS PROVIDED AND FOUND NO DEVIATIONS OR ANOMALIES AND ALL DEVICES WERE CERTIFIED STERILE PRIOR TO RELEASE FOR DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE FOUND NO PRIOR REPORTS FOR INFECTION FOR ALL THE REPORTED PART AND LOT NUMBER COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS 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

    PT REVISED FOR INFECTION AFTER (B)(6) 2010 REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DXTEND MOD EPI 1 ECC RIGHT HA 87 KWS, HSD KWS DEPUY FRANCE S.A.S. -SAINT PRIEST NA 5036824

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention