BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CORAIL AMT COLLAR SIZE 8

    MDR report key: 4092353 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28172
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 12, 2014
    Manufacturer
    DEPUY FRANCE SAS 3003895575
    Product Code
    KWA
    PMA / PMN Number
    PK042992
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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. 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

    (B)(4). THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS 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.

    Additional Manufacturer Narrative · 1

    FROM THE COMMUNICATED ELEMENTS, IT WAS CARRIED OUT: -A DHR ANALYSIS BATCH 5033940 WAS MANUFACTURED IN 2010. THIS BATCH WAS INITIALLY IN CONFORMANCE WITH REGARDS TO ITS SPECIFICATION. FOR THIS BATCH, THERE WAS NO DEVIATION OR NON-CONFORMANCE. THE HAC COATING WAS PERFORMED IN (B)(6). -A PRODUCT ANALYSIS OF THE RETURNED PRODUCTS SHOW A DISAPPEARANCE OF THE HYDROXYAPATITE, WHICH CAN BE EXPLAINED BECAUSE NATURALLY THE HUMAN ORGANISM INTEGRATES AND ABSORBS THIS COATING IN THE MONTHS WHICH FOLLOW THE IMPLEMENTATION, THE ABSENCE OF OSSEOINTEGRATION IS NOTED. THE PRODUCT WAS CHECKED DIMENSIONALLY AT VARIOUS PLACES (DWG-8H200001/ B AND MPS-S0201 / C). THE PRODUCT IS IN CONFORMITY WITH ITS DEFINITION. NO X-RAYS OR MEDICAL REPORTS WERE PROVIDED FOR ANALYSIS. THE ROOT CAUSE COULD NOT BE DETERMINED FROM THE ANALYSIS PERFORMED. THE SURGEON MENTIONED THAT THE STEM LOOKED A LITTLE UNDER-SIZED ON X-RAY, THIS COULD HAVE CONTRIBUTED TO THE LOOSENING OF THE STEM. THE ISSUE WILL BE MONITORED DURING POST MARKET SURVEILLANCE REVIEWS AS PER SEP-419 DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    CORAIL STEM FAILED TO FIX TO BONE. ON REVISING THE STEM, THE HA COATING WAS STRIPPED FROM STEM. STEM WAS FREE AND SPINNING IN FEMORAL CANAL ON REVISION. CORAIL STEM WAS REMOVED DUE TO PATIENT COMPLAINING OF PAIN. STEM WAS LOOSE ON X-RAY AND LIFTED OUT OF FEMORAL CANAL WITHOUT THE AID OF INSTRUMENTATION ON REVISION. HAS MENTIONED THAT THE STEM LOOKED A LITTLE UNDER-SIZED ON X-RAY, WHICH COULD HAVE CONTRIBUTED TO THE LOOSENING OF THE STEM. HE WOULD HOWEVER, STILL LIKE AN INVESTIGATION TO TAKE PLACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573156 CORAIL AMT COLLAR SIZE 8 HIP OTHER IMPLANT KWA DEPUY FRANCE SAS 3003895575 5033940

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention