BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCM MAXIM PRIMARY TIBIAL BEARING - ARCOM UHMWPE

    MDR report key: 6964774 · Received October 20, 2017

    Report

    Report Number
    0001825034-2017-09369
    Event Type
    Injury
    Date Received
    October 20, 2017
    Date of Event
    January 31, 2018
    Report Date
    March 12, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS - UNKNOWN MAXIM FEMUR, UNKNOWN MAXIM TIBIAL TRAY. IT IS UNKNOWN IF PRODUCT WILL BE RETURNING TO ZIMMER BIOMET AND THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 140011 MAXIM ILOK ANA PRI FML 60 RT 241890, 141232 BIOMET CC CRUCIATE TRAY 67MM 189830. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER.DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED 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 PATIENT MAY REQUIRE A BEARING REVISION PROCEDURE DUE TO INSTABILITY. HOWEVER, NO REVISION HAS BEEN REPORTED TO DATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION PROCEDURE DUE TO INSTABILITY AND WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744732 DCM MAXIM PRIMARY TIBIAL BEARING - ARCOM UHMWPE KNEE, PROSTHESIS JWH ZIMMER BIOMET, INC. N/A 389110 

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R