BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINER PROVISIONAL

    MDR report key: 8039096 · Received November 5, 2018

    Report

    Report Number
    0001822565-2018-05892
    Event Type
    Malfunction
    Date Received
    November 5, 2018
    Date of Event
    October 3, 2018
    Report Date
    May 1, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE EVENT OCCURRED IN CANADA. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF DEVICE IDENTIFIED MULTIPLE FORMS OF DAMAGE INCLUDING GOUGES, NICKS, DINGS, AND METAL IMBEDDED DEBRIS. THE SCALLOPED EDGE AROUND THE LINER HAD FRACTURED AND THE FRACTURED PIECES WERE NOT RETURNED. IT IS UNKNOWN HOW MANY TIMES THE DEVICE WAS USED DURING THIS FIELD LIFE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. INFORMATION PROVIDED IN THE PACKAGE INSERT FOR THE PROVISIONALS, INSTRUMENT/ PROVISIONAL USE AND CARE (87-6203-697-00 REV J), STATES: "USE ONLY INSTRUMENTS AND PROVISIONALS SPECIFICALLY DESIGNED FOR USE WITH THEIR ASSOCIATED DEVICES." THEREFORE, THE ROOT CAUSE OF THE EVENT OF INSTRUMENT FRACTURE CAN BE ATTRIBUTED TO OFF-LABEL USE OF THE DEVICES. A SUMMARY OF THE INVESTIGATION WAS SENT TO THE COMPLAINANT CONVEYING PROPER SURGICAL TECHNIQUE AND USE OF THE DEVICE. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TRIALS WERE FRACTURED WHEN THE EXPLANT BLADES WERE BEING USED TO REMOVE A CUP. NO SERIOUS INJURY REPORTED. SURGERY WAS COMPLETED WITH ANOTHER PRODUCT. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877605 LINER PROVISIONAL INSTRUMENT, HIP HWT ZIMMER BIOMET, INC. N/A 61190819

    Patients

    Seq Age Sex Outcome Treatment
    1