BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 79MM

    MDR report key: 11692422 · Received April 20, 2021

    Report

    Report Number
    0001825034-2021-01134
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    August 26, 2016
    Report Date
    April 19, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 183132 - VAN PS OPEN INTL FEM-LT 70 - 307660; 184770 - SERIES A PAT STD 40 3 PEG - 237000; 183766 - VNGD PS+ TIB BRG 16X79/83MM - 835480; 402282 - COBALT HV BONE CEMENT 40G - 604880. 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 REVISION PROCEDURE WITH NO INDICATION OF INFECTION, MINIMAL BONE LOSS, MINIMAL SYNOVITIS. FEMORAL COMPONENT WELL FIXED. TIBIAL COMPONENT HAD SEPARATED FROM CEMENT BONE INTERACT. NO COMPLICATIONS NOTED. 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 THE PATIENT UNDERWENT A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION DUE TO LOOSENING APPROXIMATELY 1.5 YEARS LATER. NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591397 BIOMET CC CRUCIATE TRAY 79MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3358918

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R