BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CRUCIATE TIBIAL TRAY

    MDR report key: 7397858 · Received April 4, 2018

    Report

    Report Number
    0001825034-2018-02354
    Event Type
    Injury
    Date Received
    April 4, 2018
    Date of Event
    March 7, 2018
    Report Date
    October 17, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY UPDATED AND ADDITIONAL INFORMATION. UDI# (B)(4). COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. VISUAL INSPECTION OF RETURNED TIBIAL TRAY AND FEMUR IDENTIFIED LITTLE TO NO CEMENT FIXATION ON THE POSTERIOR SIDE OF THE IMPLANTS. THE PATELLAR COMPONENT ALSO SHOWS NO SIGNS OF CEMENT FIXATION AND ONE OF THE PEGS APPEARS TO HAVE BEEN CUT OFF. THE PEG WAS LIKELY CUT OFF DURING EXPLANATION. THE TIBIAL BEARING HAS SOME SMALL NICKS AND GOUGES ON THE SUPERIOR SURFACE. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A DEFINITIVE ROOT CAUSE OF THE LOOSENING CANNOT BE DETERMINED. THE PRODUCTS WERE LIKELY CONFORMING WHEN THEY WERE RELEASED FROM ZIMMER BIOMET CONTROL. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2018 - 02353 - 3.

    Additional Manufacturer Narrative · 0

    THE FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: VANGUARD POSTERIOR STABILIZED TIBIAL BEARING, CATALOG #: EP-183660, LOT #: 915390, VANGUARD INTERLOK FEMORAL COMPONENT, CATALOG #: 183108, LOT #: 967260, ARCOM SERIES-A STANDARD PATELLA, CATALOG #: 184764, LOT #: 494670, UNKNOWN PALACOS BONE CEMENT, CATALOG #: UNKNOWN, LOT #: UNKNOWN. CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2018-02353, 0001825034-2018-02354.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN AT THE TIME OF THE INITIAL MEDWATCH. PRODUCT HAS BEEN RECEIVED BY ZIMMER BIOMET AND 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 THE PATIENT WAS REVISED TO ADDRESS COMPONENT LOOSENING AND PAIN. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240271 BIOMET CRUCIATE TIBIAL TRAY PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A J3687182

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R