BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROP DOWN STEM EXTENSION

    MDR report key: 9111605 · Received September 24, 2019

    Report

    Report Number
    0001822565-2019-04165
    Event Type
    Malfunction
    Date Received
    September 24, 2019
    Date of Event
    September 4, 2019
    Report Date
    March 24, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K043104
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL EXAMINATION OF THE RETURNED TIBIAL COMPONENT AND STEM EXTENSION IDENTIFIED SIGNS OF USE (NICKS AND GOUGES) AND THE DEVICES REMAIN ASSEMBLED. DIMENSIONAL ANALYSIS WAS PERFORMED AND THE RESULTS WERE WITHIN SPECIFICATION. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO DEVIATIONS OR ANOMALIES DURING MANUFACTURING RELATED TO THE REPORTED EVENT. PER THE SURGICAL TECHNIQUE, IT IS STATED TO "USE THE MIS 6 MM HEX SCREWDRIVER TO COMPLETELY HAND TIGHTEN THE THREADED MIS DROP DOWN STEM EXTENSION INTO THE MIS TIBIAL COMPONENT UNTIL HEAD IS BELOW PLATE SURFACE)." A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. 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 · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DEVICE PRODUCT CODE: EHD. UNIQUE IDENTIFIER (UDI) #: N/A. CONCOMITANT MEDICAL PRODUCTS: PART # 00595002702, STEMMED TIBIAL COMPONENT, LOT # 64179499. FOREIGN SOURCE: EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0002648920-2019-00709.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TKA, THE TIBIAL COMPONENT WOULD NOT SEAT WITH DROP DOWN STEM. SURGERY WAS COMPLETED WITH NEW COMPONENTS. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907577 DROP DOWN STEM EXTENSION PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 64163510

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R