BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCCK TIBIAL STEM COMPONENT

    MDR report key: 9646402 · Received January 30, 2020

    Report

    Report Number
    0001822565-2020-00393
    Event Type
    Injury
    Date Received
    January 30, 2020
    Date of Event
    January 6, 2020
    Report Date
    April 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. 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 IS AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER (B)(4). CONCOMITANT MEDICAL PRODUCTS: KNE-LCCK-BEARINGS-UNK; P/N: UNK, L/N: UNK, KNE-LCCK-TIBIAL TRAYS-UNK; P/N: UNK, L/N: UNK, KNE-LCCK-TIBIAL TRAYS STEMS-UNK; P/N: UNK, L/N: UNK, KNE-LCCK-FEMORALS-UNK; P/N: UNK, L/N: UNK, KNE-LCCK-FEMORALS STEMS-UNK; P/N: UNK, L/N: UNK, KNE-LCCK-AUGMENTS-UNK; P/N: UNK, L/N: UNK, KNE-LCCK-PATELLAS-UNK; P/N: UNK, L/N: UNK. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001822565 - 2020 - 00391, 0001822565 - 2020 - 00392, 0001822565 - 2020 - 00393, 0001822565 - 2020 - 00394, 0001822565 - 2020 - 00395, 0001822565 - 2020 - 00397. PRODUCT LOCATION IS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112485 LCCK TIBIAL STEM COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R