BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 13

    MDR report key: 2944372 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-01425
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    August 3, 2010
    Report Date
    January 8, 2013
    Manufacturer
    DEPUY FRANCE
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

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

    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 PART AND LOT CODE COMBINATIONS. PHYSICIAN STATES A +1.5 HEAD WAS THE MAXIMUM LENGTH OF HEAD THAT WAS ALLOWED FOR REDUCTION OF THE HIP DURING INITIAL SURGERY, WHICH LEFT THE PATIENTS RIGHT LEG SHORT BY APPROXIMATELY 5 TO 6 MM. NO PRODUCT PROBLEM WAS IDENTIFIED. BASED ON THE PERFORMED INVESTIGATION, 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

    UPDATE: 1/8/2013 - LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY WALKING. THE DOI WAS ALSO PROVIDED, (B)(6) 2008. THE MDR DECISION HAS BEEN REVERSED AND ALL PRODUCTS REPORTED. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS A LEG LENGTH DISCREPANCY. UPDATE 1/8/2013- LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, AND DIFFICULTY WALKING. THE DOI WAS ALSO PROVIDED, (B)(6) 2008. THE MDR DECISION HAS BEEN REVERSED AND ALL PRODUCTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48925 CORAIL2 STD SIZE 13 STEM KWA DEPUY FRANCE 2423562

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention