BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 NON COL HO SIZE 12

    MDR report key: 4911800 · Received July 14, 2015

    Report

    Report Number
    1818910-2015-25620
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 3, 2015
    Manufacturer
    DEPUY FRANCE SAS - 3003895575
    Product Code
    KWL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    ATTORNEY

    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. WWCAPA (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. (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT: RECOMMENDED ASR REVISION. BI-LATERAL. ASR XL ACETABULAR SYSTEM (RIGHT). REASON(S) FOR REVISION: PAIN. UPDATE: LOT NUMBERS, DATE OF REVISION, REASON FOR REVISION, HOSPITAL, SYSTEM AND REVISED HIP FROM (B)(6) SPREADSHEET DATED 17 JAN 2012. LOT NOS. 2903713, 2876219 AND 2924849 FOR LEFT HIP NOT REVISED. UPDATE- RIGHT- ADDED A STEM, TAKEN FROM (B)(6) DATED 21ST NOVEMBER 2012. UPDATE: 9 JULY 2015 UPDATED TO LEGAL WITH (B)(6) REFERENCE (B)(4). PRODUCTS FOR LEFT AND RIGHT HIPS WERE RECORDED ON THE SAME DINT. TWO COMS NOW CREATED, ONE FOR EACH HIP. FOR DETAILS OF LEFT HIP SEE (B)(4). ADDED MANUFACTURE AND EXPIRY DATES FOR PRODUCTS. TAKEN FROM (B)(6) ALERT 3 JULY 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455686 CORAIL2 NON COL HO SIZE 12 HIP FEMORAL STEM/SLEEVE KWL DEPUY FRANCE SAS - 3003895575 5020088

    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 +8