BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA POROUS TWO PEG TIBIAL COMPONENT

    MDR report key: 6033338 · Received October 17, 2016

    Report

    Report Number
    0001822565-2016-03701
    Event Type
    Injury
    Date Received
    October 17, 2016
    Report Date
    June 29, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    Z-1266-2015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. REVIEW OF INITIAL SURGERY OPERATIVE NOTES IDENTIFIED NO DEVIATIONS IN THE SURGICAL TECHNIQUE. REVIEW OF OPERATIVE NOTES DURING SUB-CHONDROPLASTY IDENTIFIED LOOSENING OF TIBIA AT BASEPLATE. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A PRIOR RECALL WAS INITIATED IN WHICH ZIMMER VOLUNTARILY REMOVED THE PERSONA TRABECULAR METAL TIBIA FROM THE FIELD DUE TO A HIGHER THAN ANTICIPATED COMPLAINT RATE FOR RADIOLUCENT LINES AND LOOSENING. THE ROOT CAUSE CAN BE DETERMINED AS A PREVIOUSLY ADDRESSED DESIGN ISSUE. 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 IS REPORTED THAT THE PATIENTS IS EXPERIENCING TIBIAL COMPONENT LOOSENING AFTER A KNEE ARTHROPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686591 PERSONA POROUS TWO PEG TIBIAL COMPONENT KNEE PROSTHESIS OIY ZIMMER, INC. N/A 62423349

    Patients

    Seq Age Sex Outcome Treatment
    1 Other