BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 71MM

    MDR report key: 11777160 · Received May 5, 2021

    Report

    Report Number
    0001825034-2021-01389
    Event Type
    Injury
    Date Received
    May 5, 2021
    Date of Event
    April 13, 2021
    Report Date
    May 11, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; THEREFORE, VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL RECORDS WERE NOT PROVIDED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED FOR DEVIATIONS AND/ OR ANOMALIES WITH NO DEVIATIONS / ANOMALIES IDENTIFIED. A DEFINITIVE ROOT CAUSE CANNOT 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 FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS-MEDICAL PRODUCT: VNGD CR LIP TIB BRG 10X71/75, ITEM# 183540, LOT# 187490. DEVICE EVALUATED BY MFR: CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. 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 WAS REPORTED THAT A PATIENT WAS REVISED DUE TO A LOOSE TIBIAL COMPONENT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673595 BIOMET CC CRUCIATE TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J6236658

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10