BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CRUCIATE TIBIAL TRAY 71MM

    MDR report key: 11692386 · Received April 20, 2021

    Report

    Report Number
    0001825034-2021-01135
    Event Type
    Injury
    Date Received
    April 20, 2021
    Date of Event
    October 23, 2019
    Report Date
    May 12, 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
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE IDENTIFIED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED WITH THE INFORMATION PROVIDED. 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 DEVICES - BIOMET SERIES A STANDARD PATELLA 34MM CATALOG #: 184766 LOT #: 938860, VANGUARD POSTERIOR STABILIZED OPEN INTERLOK FEMORAL COMPONENT RIGHT 62.5MM CATALOG #: 183106 LOT #: 941500, VANGUARD POSTERIOR STABILIZED TIBIAL BEARING 10MM X 71/75MM CATALOG #: 183640 LOT #: 855200. THE COMPLAINANT HAS INDICATED THAT THE PRODUCT IS NOT AVAILABLE TO BE RETURNED TO ZIMMER BIOMET FOR INSTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. INVESTIGATION INCOMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS PAIN AND TIBIAL LOOSENING APPROXIMATELY FIVE (5) YEARS POST-OPERATIVELY. INITIAL OPERATIVE NOTES DID NOT IDENTIFY ANY INTRAOPERATIVE COMPLICATIONS. REVISION OPERATIVE NOTES NOTED THAT THE TIBIAL COMPONENT WAS LOOSE AND EASILY REMOVED WHILE THE FEMORAL AND PATELLAR COMPONENTS WERE FOUND TO BE WELL-FIXED. ATTEMPTS HAVE BEEN MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591143 BIOMET CRUCIATE TIBIAL TRAY 71MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J3417409

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R