BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL2 STD SIZE 12

    MDR report key: 6105390 · Received November 16, 2016

    Report

    Report Number
    1818910-2016-31486
    Event Type
    Injury
    Date Received
    November 16, 2016
    Date of Event
    April 29, 2016
    Report Date
    November 15, 2016
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    K042292
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DESCRIPTION STATES THAT A PATIENT HAD A REVISION OF A HIPS PROSTHESIS AFTER A SPONTANEOUS FRACTURE OF THE NECK OF THE FEMORAL STEM, GENERATING AN IMPOTENCE OF THE LOWER LEFT LIMB. THE DEVICE ASSOCIATED TO THE COMPLAINT WAS NOT RETURNED FOR ANALYSIS. NO DHR REVIEW WAS PERFORMED. A RECALL WAS PERFORMED IN 2004 CONCERNING CORAIL AMT STEMS. THE REFERENCE S CONCERNED BY THIS RECALL WERE THE FOLLOWING : (B)(4) 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. THE REFERENCE / BATCH INVOLVED IN THE CURRENT COMPLAINT (B)(4) IS PART OF THE BATCHES CONCERNED BY THE RECALL. AS A CONSEQUENCE, THE ROOT CAUSE OF THE NECK FRACTURE IS THE ETCHING LOCATED ON THE NECK. DEPUY STILL CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    REVISION OF A HIPS PROSTHESIS AFTER A SPONTANEOUS FRACTURE OF THE NECK OF THE FEMORAL STEM, GENERATING AN IMPOTENCE OF THE LOWER RIGHT LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756853 CORAIL2 STD SIZE 12 HIP FEMORAL STEM/SLEEVE KWA DEPUY FRANCE SAS 3003895575 1241127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention