BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER NEXEL TOTAL ELBOW HUMERAL SCREW KIT

    MDR report key: 19850990 · Received July 29, 2024

    Report

    Report Number
    0001822565-2024-02471
    Event Type
    Malfunction
    Date Received
    July 29, 2024
    Date of Event
    July 2, 2024
    Report Date
    October 17, 2024
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JDC
    PMA / PMN Number
    K181307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D10: ASSOCIATED PRODUCT INFORMATION, PART (LOT): 32810538 (66785944), 47225500800 (66166086), 47840103800 (65606446), 00840009500 (66197838), 00840002511 (65843364), 110029938 (65696957), 211269 (689090), 211237 (999100). THE CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND THAT 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 · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE REPORTED EVENT IS UNABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING. MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN INITIAL PROCEDURE, ONE OF THE HUMERAL SCREWS STRIPPED DURING IMPLANTATION. THE CORRECT SURGICAL TECHNIQUE WAS USED. NO COMPLICATIONS, INJURIES, OR SURGICAL INTERVENTIONS WERE REQUIRED, AND NO FOREIGN BODIES WERE RETAINED DUE TO THIS MALFUNCTION. THE CASE WAS COMPLETED WITH THE SCREW WITHOUT ANY ADVERSE OUTCOMES TO THE PATIENT. ATTEMPTS HAVE BEEN MADE, AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    950979 ZIMMER NEXEL TOTAL ELBOW HUMERAL SCREW KIT PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED JDC ZIMMER BIOMET, INC. NI 66667711

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male