BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 9

    MDR report key: 3200422 · Received July 1, 2013

    Report

    Report Number
    1818910-2013-20268
    Event Type
    Injury
    Date Received
    July 1, 2013
    Date of Event
    February 10, 2009
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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, ASR XL ACETABULAR SYSTEM, REASON(S) FOR REVISION: PAIN, ALVAL, METALLOSIS, ACETABULAR CUP HAS LOOSENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300291 CORAIL2 STD SIZE 9 STEM KWA DEPUY FRANCE SAS - 3003895575 2429608

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASR ACETABULAR IMPLANT 48.| DEPUY ASR XL FEM IMP SIZE 43.| TAPER SLEEVE ADAPTER 12/14 +2.