BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA PS VE ARTICULAR SURFACE

    MDR report key: 6057086 · Received October 26, 2016

    Report

    Report Number
    0001822565-2016-03795
    Event Type
    Malfunction
    Date Received
    October 26, 2016
    Date of Event
    October 4, 2016
    Report Date
    September 11, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    OIY
    PMA / PMN Number
    PK121771
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT IS CONSIDERED CONFIRMED AS THE RETURNED DEVICE IS DAMAGED AND THE STATE OF THE LOCKING MECHANISM WOULD NOT PERMIT ITS MATING WITH AN APPROPRIATE TIBIAL COMPONENT. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THE LIKELY CONDITION OF THE PART WHEN IT LEFT ZIMMER BIOMET CONTROL IS CONSIDERED CONFORMING BASED ON THE RETURNED PART AND DHR REVIEW. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT. 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

    A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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 ARTICULAR SURFACE COULD NOT BE INSERTED INTO THE TIBIA COMPONENT PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707935 PERSONA PS VE ARTICULAR SURFACE KNEE PROSTHESIS OIY ZIMMER, INC. 62992660

    Patients

    Seq Age Sex Outcome Treatment
    1