BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NKII CEM CCK FEM SZ2-RT

    MDR report key: 8407473 · Received March 11, 2019

    Report

    Report Number
    0001822565-2019-00677
    Event Type
    Malfunction
    Date Received
    March 11, 2019
    Date of Event
    February 6, 2019
    Report Date
    October 12, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K973412
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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). CONCOMITANT MEDICAL PRODUCTS: NKII CEM CCK FEM SZ2-RT; P/N: 632000202, L/N: 62640360. CEMENTED CONSTRAINED FEMORAL; P/N: 632000200, L/N: 62354042. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING SURGERY THAT THE NECESSARY STEM SET SCREW WAS MISSING. SUBSEQUENTLY, THE ANOTHER IMPLANT WAS OPENED AND THE SET SCREW FROM THAT SET WAS USED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201142 NKII CEM CCK FEM SZ2-RT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 62640360

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR