BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NP STM TIB B/P LT SZ2 NAT

    MDR report key: 16387183 · Received February 16, 2023

    Report

    Report Number
    0001822565-2023-00410
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    February 13, 2023
    Report Date
    April 11, 2023
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K936159
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EXACT IMPLANT DATE IS UNKNOWN BUT IT HAS BEEN REPORTED THAT IMPLANTATION OCCURRED IN 2007 OR 2009. CONCOMITANT MEDICAL PRODUCTS: NK SZ3 LT FEMUR TI: CATALOG#620000030, LOT#60446807; TIB INS LT SZ1/2 13MM N-K II: CATALOG#627501613, LOT#1580111; PALACOS R+G 2X20G KPG: CATALOG#NI, LOT#617D0E0801. REPORT SOURCE - FOREIGN: GERMANY. DUE DILIGENCE IS IN PROGRESS TO DETERMINE IF THE DEVICE IS AVAILABLE FOR EVALUATION. THE INVESTIGATION IS IN PROGRESS. UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. VISUAL AND DIMENSIONAL EVALUATIONS OF THE PRODUCT COULD NOT BE PERFORMED AS NO PRODUCT WAS RETURNED NOR WERE PICTURES PROVIDED. 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. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, BETWEEN FOURTEEN (14) AND SIXTEEN (16) YEARS POST-IMPLANTATION, THE PATIENT PRESENTED TO THE CLINIC WHERE IT WAS DETERMINED THAT THE TIBIAL TRAY HAD FRACTURED. THE PATIENT UNDERWENT REVISION SURGERY AND ALL COMPONENTS WERE REVISED. DUE DILIGENCE IS IN PROCESS FOR THIS EVENT; TO DATE NO FURTHER INFORMATION HAS BEEN REPORTED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AT TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390412 NP STM TIB B/P LT SZ2 NAT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Prefer Not To Disclose Required Intervention| H