BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK)

    MDR report key: 17341628 · Received July 18, 2023

    Report

    Report Number
    0001822565-2023-01889
    Event Type
    Malfunction
    Date Received
    July 18, 2023
    Date of Event
    June 23, 2023
    Report Date
    October 27, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    MBH
    UDI-DI
    00889024555310
    PMA / PMN Number
    K191625
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE WAS NOT RETURNED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE CANNOT BE DETERMINED FOR THE MATING ISSUE. 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 · 0

    (B)(4). D11: MEDICAL DEVICE TIBIA FIXED CEMENTED CATALOG # 42542007502 LOT # 65652668. G2: JAPAN. H3: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED BECAUSE IT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. H3 OTHER TEXT : REMAINS IMPLANTED.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEVICE WOULD NOT MATE WITH MATING COMPONENT DURING PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169936 ARTICULAR SURFACE FIXED BEARING CONSTRAINED CONDYLAR KNEE (CCK) PROSTHESIS KNEE MBH ZIMMER BIOMET, INC. N/A 65128553 00889024555310

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown SEE H10 NARRATIVE.