BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 11

    MDR report key: 3052124 · Received April 11, 2013

    Report

    Report Number
    1818910-2013-15204
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 19, 2015
    Report Date
    March 26, 2013
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES AND/OR A REVIEW OF DEVICE HISTORY RECORDS WERE NOT POSSIBLE AS THE REQUIRED PRODUCT/LOT CODE COMBINATIONS WERE NOT PROVIDED. REASON FOR REVISION HAS NOT BEEN PROVIDED AND NO FURTHER DETAILS REGARDING THE EVENT HAVE BEEN MADE AVAILABLE TO CUSTOMER QUALITY. THE INVESTIGATION CAN DRAW NO CONCLUSION REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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

    CONFIRMED REVISION OF PINNACLE MOM IMPLANTS. REASON NOT PROVIDED, REVISION DATE CONFIRMED.

    Description of Event or Problem · 1

    UPDATE OCT 9, 2017 AND OCT 19, 2017: ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS PAIN. UPDATED PART AND LOT INFORMATION OF THE CUP, LINER AND STEM. ADDED COMPLAINANT INFORMATION. THIS COMPLAINT WAS UPDATED ON: OCT 24, 2017

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155455 CORAIL AMT COLLAR SIZE 11 HIP STEM KWA DEPUY FRANCE SAS 3003895575 2488006

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention