BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTA CERAMIC FEM HD 36/0MM

    MDR report key: 7581483 · Received June 8, 2018

    Report

    Report Number
    3002806535-2018-00876
    Event Type
    Malfunction
    Date Received
    June 8, 2018
    Date of Event
    May 1, 2018
    Report Date
    November 7, 2018
    Manufacturer
    BIOMET UK LTD.
    Product Code
    LPH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PACKAGING HAVE BEEN RETURNED TO BIOMET UK LTD FOR EVALUATION. THE VISUAL INSPECTION HAS CONFIRMED THE REPORTED ISSUE. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A REVIEW OF THE COMPLAINT DATABASE HAS FOUND NO SIMILAR COMPLAINTS REPORTED WITH THIS ITEM # / LOT # COMBINATION. A TREND HAS BEEN IDENTIFIED REGARDING ISSUES WITH THE TYVEK LID STICKING TO THE TOP FOAM ON VARIOUS IMPLANTS, WHICH CAUSE THE IMPLANT TO FALL OUT OF THE BLISTER PACK WHEN OPENED IN SURGERY. AS A RESULT OF THIS TREND AN (B)(4) HAS BEEN INITIATED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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 · 1

    IT WAS REPORTED THAT THE CIRCULATING NURSE OPENED PACKAGING. THE STYROFOAM PADDING WAS STUCK TO THE PULL TAB. THE STYROFOAM PULLED OFF PARTIALLY ALMOST COMPROMISED THE STERILE IMPLANT.

    Description of Event or Problem · 1

    THE FOAM PADDING IS STUCK TO THE TYVEK LID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426696 DELTA CERAMIC FEM HD 36/0MM LPH BIOMET UK LTD. N/A 2017050058

    Patients

    Seq Age Sex Outcome Treatment
    1