BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 11

    MDR report key: 3933543 · Received July 15, 2014

    Report

    Report Number
    1818910-2014-23360
    Event Type
    Injury
    Date Received
    July 15, 2014
    Date of Event
    February 19, 2013
    Report Date
    December 8, 2015
    Manufacturer
    DEPUY FRANCE SAS-3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. (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.

    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. DEPUY STILL CONSIDERS THIS CASE CLOSED TO CAPA.

    Description of Event or Problem · 1

    ASR REVISION; ASR XL; LEFT; REASON(S) FOR REVISION: PAIN.

    Description of Event or Problem · 1

    UPDATE 9 DEC. 2015: UPDATED AS BILATERAL. UPDATED DOI AND ADDED EXPIRY DATES TO PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414356 CORAIL2 STD SIZE 11 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS-3003895575 2136658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention