BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERAMAX CERAMIC INSERT 28 X 50

    MDR report key: 3873856 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-21024
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 5, 2014
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    MRA
    PMA / PMN Number
    PP070026
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES BY THE MANUFACTURING SUPPLIER CONFIRMS THE REPORTED MATERIAL FRACTURE. THE ROOT CAUSE WAS FOUND TO HAVE BEEN A MISALIGNED POSITION OF THE INSERT IN THE METAL SHELL. DUE TO THE MISALIGNMENT THERE WERE POINT CONTACTS BETWEEN THE METAL SHELL AND THE INSERT WHICH INITIATED THE FRACTURE. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DENSITY OF THE INSERT WAS ANALYSED AND FOUND TO BE COMPLYING WITH THE DELIVERY SPECIFICATION FOR BIOLOX®DELTA COMPONENTS. THE MICROSTRUCTURES AS OBTAINED FROM THE QUALITY DOCUMENTS ACCOMPLISH THE REQUIREMENTS AS SPECIFIED AT THE TIME OF PRODUCTION, TOO. THERE ARE NO INDICATIONS OF ANY PRE-EXISTING MATERIAL DEFECT. BASED ON THE PERFORMED INVESTIGATION, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE REOPENED 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.

    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.

    Description of Event or Problem · 1

    DURING IMPACTION OF CERAMIC LINER CERAMIC DELAMINATED ON RIM ON ONE SIDE. SURGEON WANTED TO DO OFF LABEL USE OF A CERAMIC LINER WITH A GRIPTON CUP. LARGE PIECE OF LINER IS WHAT CAME OFF DURING IMPACTION AND SMALLER PIECES HAPPENED DURING REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353424 CERAMAX CERAMIC INSERT 28 X 50 HIP ACETABULAR INSERT/LINER MRA DEPUY IRELAND 9616671 6299312

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR