BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING

    MDR report key: 6673592 · Received June 28, 2017

    Report

    Report Number
    0001825034-2017-04388
    Event Type
    Malfunction
    Date Received
    June 28, 2017
    Date of Event
    May 26, 2017
    Report Date
    January 10, 2018
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    KWS
    PMA / PMN Number
    PK113069
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF THE LOCKING RING WITHIN THE TRAY SHOWS TINE EDGE (LEFT) HAS THE SLIGHTEST BEND AND BOTH HAVE SLIGHT PIT MARKS. THE LOCKING RING DOES NOT MOVE SMOOTHLY WITHIN THE TRAY. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). CONCOMITANT DEVICES - COMPREHENSIVE REVERSE PRIMARY MINI STEM 8MM CATALOG #: 113628 LOT #: 842690. THE 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 IS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, THE LOCKING RING OF THE HUMERAL TRAY WOULD NOT ENGAGE WHEN THE SURGEON ATTEMPTED TO ASSEMBLE THE POLYETHYLENE LINER TO THE HUMERAL TRAY. AN ADDITIONAL HUMERAL TRAY WAS OPENED AND THE SURGEON WAS ABLE TO ASSEMBLE THE IMPLANTS WITHOUT FURTHER ISSUE. NO ADVERSE EVENTS HAVE BEEN REPORTED AS A RESULT OF THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455611 COMPREHENSIVE REVERSE HUMERAL TRAY WITH LOCKING RING PROSTHESIS, SHOULDER KWS BIOMET ORTHOPEDICS N/A 271640

    Patients

    Seq Age Sex Outcome Treatment
    1