BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 67MM

    MDR report key: 11687711 · Received April 19, 2021

    Report

    Report Number
    0001825034-2021-01126
    Event Type
    Injury
    Date Received
    April 19, 2021
    Date of Event
    March 2, 2020
    Report Date
    April 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00887868247958
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: 183020 - FEMORAL COMPONENT - J3700866. EP-183426 - BEARING - 992620. 60015100 - COBALT BONE CEMENT - 820C2D001. 184764 - PATELLA - 692610. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. THE DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. MEDICAL RECORDS WERE PROVIDED AND REVIEWED BY A HEALTH CARE PROFESSIONAL. REVIEW FOUND SYMPTOMATIC LOOSENING OF THE TIBIAL COMPONENT. THE TIBIAL COMPONENT WAS REMOVED WITHOUT SIGNIFICANT DIFFICULTY BECAUSE OF A VERY WELL-DEFINED INTERFACE AND COMPLETE LACK OF ADHERENCE OF THE CEMENT TO THE IMPLANT ITSELF. CEMENT MANTLE COMPLETELY INTACT. FEMORAL COMPONENT WITHIN NORMAL LIMITS. TIBIA AND BEARING REPLACED, ALL OTHER COMPONENTS LEFT INTACT. A DEFINITIVE ROOT CAUSE CANNOT 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 · 1

    IT WAS REPORTED BY LEGAL THAT A PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT APPROXIMATELY 1 YEAR POST IMPLANTATION. DURING THE REVISION, A COMPLETE LACK OF ADHERENCE OF THE CEMENT TO THE TIBIAL IMPLANT WAS NOTED. THE TIBIAL COMPONENT AND BEARING WERE REVISED WITHOUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585539 BIOMET CC CRUCIATE TRAY 67MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6420877 00887868247958

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R