BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN NATURAL KNEE II FEMORAL COMPONENT

    MDR report key: 10638131 · Received October 6, 2020

    Report

    Report Number
    0001822565-2020-03453
    Event Type
    Injury
    Date Received
    October 6, 2020
    Date of Event
    September 8, 2020
    Report Date
    October 16, 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

    REPORTED EVENT WAS UNABLE TO CONFIRMED DUE TO LIMITED INFORMATION PROVIDED BY THE CUSTOMER. DHR WAS UNABLE TO BE REVIEWED AS THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. THE ROOT CAUSE IS UNABLE TO BE DETERMINED. 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 ADDITIONAL EVENT INFORMATION TO REPORT AT THIS TIME.

    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. DATE OF EVENT: THE ARTICLE WAS PUBLISHED ON (B)(6) 2020 CONCOMITANT MEDICAL PRODUCTS: UNKNOWN NATURAL KNEE II TI.BIAL COMPONENT, CATALOG #: NI, LOT #: NI. UNKNOWN NATURAL KNEE II ARTICULAR SURFACE, CATALOG #: NI, LOT #: NI. REPORT SOURCE - FOREIGN: (B)(6). 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 LOOSENING OF THE FEMORAL COMPONENT FOLLOWING KNEE ARTHROPLASTY. 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
    1097690 UNKNOWN NATURAL KNEE II FEMORAL COMPONENT PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other