BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNKOWN FEMORAL COMPONENT

    MDR report key: 9546418 · Received January 3, 2020

    Report

    Report Number
    0001822565-2020-00049
    Event Type
    Injury
    Date Received
    January 3, 2020
    Date of Event
    December 4, 2019
    Report Date
    January 7, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURING SITE MFR NUMBER. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. PLEASE SEE 0001825034 - 2020 - 00208.

    Description of Event or Problem · 0

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT HAS BEEN DETERMINED THAT THIS DEVICE WAS REPORTED UNDER THE INCORRECT MANUFACTURING SITE MFR NUMBER. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED. PLEASE SEE 0001825034 - 2020 - 00208.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 141210, TIBIAL TRAY, LOT # 716390, 183400, ARTICULAR SURFACE, LOT # 421320. REPORT SOURCE: EVENT OCCURRED IN (B)(6). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 00013, 0001825034 - 2020 - 00012.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 9 YEARS POST IMPLANTATION, THE PATIENT BEGAN TO EXPERIENCE PAIN AND A FEELING OF INSTABILITY WITH THE RIGHT KNEE. SUBSEQUENTLY, AT 10 YEARS POST OP, THE PATIENT WAS SEEN BY PHYSICIAN AND FOUND TO HAVE LARGE VARUS. SURGEON SUSPECTED IMMINENT FRACTURE OF IMPLANT, AND PERFORMED A REVISION DUE TO INSTABILITY AND METALLOSIS WAS ALSO OBSERVED. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11236 UNKNKOWN FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R SEE H10.