BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERSONA CCK TIBIAL ARTICULAR SURFACE PROVISIONAL

    MDR report key: 10347323 · Received July 30, 2020

    Report

    Report Number
    0001822565-2020-02647
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 10, 2020
    Report Date
    January 6, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL INSPECTION OF THE RETURNED PROVISIONAL CONFIRMED THAT THE A SMALL PIECE OF THE PROVISIONAL IS FRACTURED AT THE ANTERIOR SIDE. THE SURFACE WHERE THE PIECE HAS BROKEN SHOWS SAW BLADE MARKS INDICATING THE FRACTURE WAS DUE TO THE USAGE OF THE SAW BLADE. REVIEW OF THE DEVICE HISTORY RECORD IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. REPORTED EVENT IS NOT RELATED TO A COMBINATION OF PRODUCTS; THEREFORE A COMPATIBILITY REVIEW IS NOT APPLICABLE. REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL RELATED ISSUES FOR THIS ITEM AND THE REPORTED PART AND LOT COMBINATION. SURGICAL NOTES WERE NOT PROVIDED. THIS COMPLAINT IS CONFIRMED. THE PERSONA REVISION KNEE SYSTEM SURGICAL TECHNIQUE (1832.1-GLBL-EN-REV0819 ) STATES THAT ALL THE PROVISIONAL COMPONENTS NEED TO BE REMOVED BEFORE MAKING THE BONE CUTS AND PER EVALUATION OF THE RETURNED PRODUCT, THE SAW BLADE WAS USED DURING THE SURGERY WHICH CAUSED THE FRACTURE OF THE PROVISIONAL; HENCE THE ROOT CAUSE IS ATTRIBUTED TO USER ERROR/OFF LABEL USE. NO CORRECTIVE ACTIONS, PREVENTIVE ACTIONS, OR FIELD ACTIONS RESULTED AFTER INVESTIGATION OF THIS EVENT.

    Description of Event or Problem · 0

    FROM ADDITIONAL INFORMATION RECEIVED, IT WAS REPORTED THAT THE EVENT OCCURRED PRIOR TO PROCEDURE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT DEVICE HAS BEEN RETURNED, BUT THE DEVICE INVESTIGATION HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FRACTURED. ATTEMPT FOR FURTHER INFORMATION HAS BEEN MADE, BUT NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807831 PERSONA CCK TIBIAL ARTICULAR SURFACE PROVISIONAL PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64408389

    Patients

    Seq Age Sex Outcome Treatment
    1