BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARCOS CON SZ B HI 60MM TRL

    MDR report key: 12448026 · Received September 9, 2021

    Report

    Report Number
    0001825034-2021-02616
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    August 24, 2021
    Report Date
    January 7, 2022
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    KWA
    UDI-DI
    00880304489998
    PMA / PMN Number
    K100469
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A CONE BODY TRIAL WAS RETURNED AND EVALUATED. THERE WAS NO VISIBLE DAMAGE TO THE TAPER, HOWEVER, SHOWS SIGNS OF USAGE. REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO (RELATED) DEVIATIONS OR ANOMALIES DURING MANUFACTURING MEDICAL RECORDS WERE NOT PROVIDED. A DEFINITIVE ROOT CAUSE COULD NOT 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2021-02615.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONE BODY TRIAL WAS HAVING DIFFICULTY ATTACHING TO THE STEM. THE SCREW LOCKING MECHANISM WAS NOT CATCHING. IT DID EVENTUALLY LOCK DOWN. WHEN WE WENT TO UNLOCK THE SCREW AFTER TRIALING, THE SCREW WOULD NOT LOOSEN. WHEN LOOSENED, TIP OF DRIVER BROKE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343366 ARCOS CON SZ B HI 60MM TRL PROSTHETIC, HIP KWA ZIMMER BIOMET, INC. N/A 427427 00880304489998

    Patients

    Seq Age Sex Outcome Treatment
    1 Male