BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E-POLY TIBIAL BEARINGS

    MDR report key: 6708497 · Received July 12, 2017

    Report

    Report Number
    3002806535-2017-00581
    Event Type
    Injury
    Date Received
    July 12, 2017
    Date of Event
    June 9, 2017
    Report Date
    November 8, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). CONCOMITANT PRODUCTS: UNKNOWN AGC FEMORAL COMPONENT, CAT#: UNKNOWN LOT#: UNKNOWN; UNKNOWN AGC TIBIAL TRAY, CAT#: UNKNOWN LOT#: UNKNOWN; UNKNOWN FEMORAL STEM, CAT#: UNKNOWN LOT#: UNKNOWN; UNKNOWN TIBIAL STEM, CAT#: UNKNOWN LOT#: UNKNOWN. THIS PRODUCT IS MANUFACTURED BY ZIMMER BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER PMA NUMBER K080528. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, [NOT RETURNED BY PATIENT]. THE INVESTIGATION IS IN PROCESS. 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.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED, FIFTEEN YEARS AFTER INITIAL IMPLANTATION, TO ADDRESS BEARING WEAR. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488168 E-POLY TIBIAL BEARINGS PROSTHESIS, KNEE JWH BIOMET UK LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R