BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NATURAL KNEE II TIBIAL COMPONENT

    MDR report key: 10637723 · Received October 6, 2020

    Report

    Report Number
    0001822565-2020-03451
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 26, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    NI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PRODUCT COULD NOT BE EVALUATED AND THE REPORTED EVENT WAS NOT CONFIRMED. THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER ASSOCIATED WITH THE REPORTED EVENT IS UNKNOWN. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001822565-2020-03451, 0001822565-2020-03642, 0001822565-2020-03643.

    Description of Event or Problem · 0

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

    Additional Manufacturer Narrative · 1

    (B)(4). PACORET V, KALK E, LABATTUT L, GIRARDOT G, BAULOT E & MARTZ P (2020) SURVIVAL RATE OF CEMENTED VERSUS CEMENTLESS TIBIAL COMPONENT IN PRIMARY TOTAL KNEE ARTHROPLASTY OVER 5 YEARS OF FOLLOW-UP: COMPARATIVE STUDY OF 109 PROSTHESES. SICOT-J 6, 36 HTTPS://DOI.ORG/10.1051/SICOTJ/2020028. THE ARTICLE WAS PUBLISHED ON SEP 8, 2020. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NATURAL KNEE II FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN NATURAL KNEE II ARTICULAR SURFACE CATALOG #: NI LOT #: NI. REPORT SOURCE - FOREIGN: (B)(4). THE COMPLAINANT HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE REMAINS IMPLANTED. 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 IS REPORTED THAT ONE PATIENT EXPERIENCED SEPTIC LOOSENING OF THE TIBIAL COMPONENT FOLLOWING KNEE ARTHROPLASTY WITH A PROGRESSIVE LINE THAT WAS CLASSIFIED AS POSSIBLE OR IMPENDING FAILURE REGARDLESS OF SYMPTOMS ACCORDING TO EWALD¿S RADIOLUCENCY SCORE. ATTEMPTS HAVE BEEN MADE AND NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1097696 UNKNOWN NATURAL KNEE II TIBIAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other