BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 3467150 · Received November 13, 2013

    Report

    Report Number
    1818910-2013-33206
    Event Type
    Injury
    Date Received
    November 13, 2013
    Date of Event
    October 15, 2009
    Report Date
    October 17, 2013
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED LOT CODES 2223671, ZG7HS1000 AND Z5XGA4000. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 2234489, 1853510 AND A36C44000 DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGES PAIN, SWELLING AND DIFFICULTY AMBULATING. UPDATE REC'D (B)(6) 2013 - PFS AND MEDICAL RECORDS RECEIVED. REVISION OPERATIVE NOTES INDICATE INFECTION. ALL PRODUCTS HAVE NOW BEEN REPORTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. RECORDS ARE ATTACHED FOR FURTHER REVIEW. THE COMPLAINT WAS UPDATED ON: (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587862 CORAIL2 NON COL HO SIZE 12 FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 1853510

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention