BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUGMENTED INSERT

    MDR report key: 3063503 · Received April 17, 2013

    Report

    Report Number
    1818910-2013-15483
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    September 11, 2012
    Report Date
    March 27, 2013
    Manufacturer
    8010379 DEPUY INTL., LTD.
    Product Code
    KWA
    PMA / PMN Number
    PK001523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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

    CONCLUSION AND JUSTIFICATION STATUS: AS THERE WERE NO PRODUCTS RETURNED, NO INVESTIGATION OF THE PRODUCTS COULD TAKE PLACE. A REVIEW OF THE MANUFACTURING RECORDS FOUND NO ANOMALIES. A SEARCH OF THE COMPLAINTS DATABASE DID FIND A NUMBER OF OTHER COMPLAINTS WITH THE SAME COMBINATION OF PRODUCTS AS THIS (ULTIMA MOM / TPS STEM). IN 2012 A FIELD SAFETY NOTICE WAS ISSUED DUE TO A NUMBER OF COMPLAINTS INVOLVING ULTIMA MOM / TPS STEM COMBINATIONS WHERE THE STEM WAS CORRODING, CAUSING PAIN AND EXTENSIVE PERIPROSTHETIC SOFT TISSUE NECROSIS. IN THIS INSTANCE THERE IS NO MENTION OF STEM CORROSION. THE COMPLAINT SHALL BE CLOSED WITH AN UNDETERMINED CONCLUSION; IT SHALL BE ENTERED ONTO THE COMPLAINTS DATABASE AND MONITORED THROUGH TREND ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED THEN THE COMPLAINT SHALL BE INVESTIGATED FURTHER.

    Description of Event or Problem · 1

    REVISED DUE TO NIGHT PAIN &, RESTRICTED RANGE OF MOVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165941 AUGMENTED INSERT AUGMENT INSERT KWA 8010379 DEPUY INTL., LTD. XWT-40

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention