BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 5771568 · Received July 6, 2016

    Report

    Report Number
    1818910-2016-22627
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    May 3, 2016
    Report Date
    June 22, 2016
    Manufacturer
    DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION STATES THAT THE PATIENT HAD AN EMERGENCY REVISION DUE TO STEM FRACTURE. THE DEVICE ASSOCIATED TO THE COMPLAINT WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE PICTURES OF THE X-RAYS CONFIRMS THE NECK FRACTURE. NO DHR REVIEW WAS PERFORMED. A SEARCH INTO THE COMPLAINTS DATABASE WAS PERFORMED, NO OTHER SIMILAR COMPLAINT WAS REPORTED FOR THE AFFECTED PRODUCT CODE(S) AND LOT(S) COMBINATION(S). A RECALL WAS PERFORMED IN 2004 CONCERNING CORAIL AMT STEMS. THE REFERENCES CONCERNED BY THIS RECALL WERE THE FOLLOWING : 3L92498 TO 3L93716 AND L20006 TO L20316 THE BATCHES CONCERNED BY THIS RECALL WERE : ALL BATCHES LESS THAN 1391546. THIS RECALL WAS PERFORMED BECAUSE THE CONCERNING PARTS WERE LASER ETCHED ON THE NECK AND SUBSEQUENTLY THERE WERE A RISK OF FRACTURE OF THE STEM. BASED ON THE INFORMATION RECEIVED AND THE INVESTIGATION PERFORMED, IT IS CONFIRMED TANT THE REFERENCE / BATCH INVOLVED IN THE CURRENT COMPLAINT (3L92512 / 1241127) IS PART OF THE BATCHES CONCERNED BY THE RECALL. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED THE INVESTIGATION WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THE INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LETTER FROM PATIENT AND DOCUMENTS FROM SURGEON RECEIVED : SEPTEMBER 27, 2003 : PATIENT GET RIGHT HIP PROSTHESIS WHICH WAS PART OF A DEFECTIVE BATCH HAVING UNDERGONE LASER MARKING (STEM REF 3L92512 / LOT 1241127) ON (B)(6) 2016 : EMERGENCY REVISION DUE TO STEM FRACTURE, CHANGE OF THE STEM, THE FEMORAL HEAD AND POLYETHYLENE PATIENT ASKS FOR A COMPENSATION FOR THE INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426887 CORAIL2 STD SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE S.A.S.-SAINT PRIEST ¿ REG# 3003895575 1241127

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention