BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 75MM MM

    MDR report key: 11665926 · Received April 14, 2021

    Report

    Report Number
    0001825034-2021-01080
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    June 12, 2020
    Report Date
    April 14, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 402282 - COBALT BONE CEMENT - 736540; 184788 - PATELLA - 598130; EP-183542 - BEARING - 107240; 183052 - FEMORAL COMPONENT - 526140. 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 RIGHT PAINFUL KNEE REPLACEMENT WITH LOOSE TIBIAL COMPONENT. PREOP XRAYS AND BONE SCAN SHOWED LOOSENING OF TIBIAL COMPONENT. SYNOVIUM WAS STAINED DARK WITH EXTENSIVE AMOUNT OF INFLAMMATORY SYNOVITIS. TIBIAL COMPONENT LIFTED AND ELEVATED OFF OF THE TIBIA QUITE EASILY, APPEARED THAT THE COBALT CEMENT DID NOT BOND TO THE TIBIAL COMPONENT. THE CEMENT DID BOND TO THE ADJACENT BONE. PATELLA AND FEMORAL COMPONENT FROM PREVIOUS SURGERY STABLE AND WELL-FIXED TO THE BONE. 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 THAT THE PATIENT WAS REVISED APPROXIMATELY 7 YEARS POST IMPLANTATION DUE TO PAIN AND LOOSENING OF THE TIBIAL COMPONENT. INTRAOPERATIVELY, INFLAMMATORY SYNOVITIS AND CEMENT NOT BONDED TO THE TIBIAL COMPONENT WAS ENCOUNTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564814 BIOMET CC CRUCIATE TRAY 75MM MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J2933143

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R