BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 3954248 · Received July 24, 2014

    Report

    Report Number
    1818910-2014-24145
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 12, 2014
    Report Date
    July 11, 2014
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. NO 510(K) NUMBER PROVIDED BECAUSE THIS IMPLANT IS SOLD INTERNATIONALLY WITH DIFFERENT INDICATIONS FOR USE; IT IS CURRENTLY SOLD IN THE US UNDER A DIFFERENT PART NUMBER. THE CORRECTION/REMOVAL REPORTING NUMBER LISTED APPLIES TO THE CORRESPONDING PRODUCT CODE SOLD DOMESTICALLY. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. REF. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    ASR REVISION, RIGHT, ASR XL, REASON(S) FOR REVISION: PAIN. UPDATE RECEIVED: (B)(6) 2014 - ADDED DCGI REFERENCE NUMBER, CORRECTED REVISION DATE: (B)(6) 2014, ADDED PATIENT INITIALS, ADDED HOSPITAL AREA: (B)(6), ADDED FURTHER HOSPITAL: (B)(6), ADDED PATIENT AGE, ADDED PATIENT GENDER AND ADDED UNKNOWN TO CUP LOT NUMBER FIELD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433696 CORAIL2 STD SIZE 11 CORAIL AMT CEMENTLESS IMPLANT : HIP FEMORAL STEM KWA DEPUY FRANCE SAS - 3003895575 2167504

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention ASR ACETABULAR IMPLANT 50| DEPUY ASR XL FEM IMP SIZE 45| TAPER SLEEVE ADAPTER 12/14 +2