BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - MAX PRI DCM TIB BRNG12X79/83MM

    MDR report key: 6333039 · Received February 15, 2017

    Report

    Report Number
    0001825034-2017-00715
    Event Type
    Injury
    Date Received
    February 15, 2017
    Date of Event
    January 31, 2017
    Report Date
    May 24, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. 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 AS NO WERE TRENDS 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: UNKNOWN MAXIM FEMORAL COMPONENT, LOT UNKNOWN. UNKNOWN TIBIAL TRAY, LOT UNKNOWN.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. CONCOMITANT PRODUCTS ¿ MAXIM RIGHT FEMUR 70MM CATALOG 140013 LOT 274680; BIOMET CRUCUTE TRAY CATALOG 141236 LOT 883680 OR 541690.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAS BEEN REVISED DUE TO HAVING A WORN TIBIAL BEARING COMPONENT AND INSTABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116904 MCK MAXIMUM CONGRUENT KNEE) KNEE SYSTEM - MAX PRI DCM TIB BRNG12X79/83MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 325090

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R