BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCM MAXIM PRIMARY TIBIAL BEARING 18MM THICK X 79/83MM WIDE

    MDR report key: 7076516 · Received December 1, 2017

    Report

    Report Number
    0001825034-2017-10750
    Event Type
    Injury
    Date Received
    December 1, 2017
    Date of Event
    December 2, 2013
    Report Date
    December 1, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES - MAXIM PRIMARY FEMORAL COMPONENT 75MM LEFT / INTERLOK CATALOG #: 140034 LOT #: 477630. THE COMPLAINT SAMPLE WAS EVALUATED, BUT THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE IDENTIFIED. A REVIEW OF THE COMPLAINT HISTORY FOR FAILURE MODE COULD NOT BE PERFORMED AS THE REASON FOR REVISION IS UNKNOWN. THE 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 WOUND CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. THIS REPORT IS NUMBER 1 OF 2 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-10751).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY REVISION OF THE BEARING AND FEMORAL COMPONENTS DUE TO UNKNOWN REASONS LESS THAN THREE MONTHS POST-OPERATIVELY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854143 DCM MAXIM PRIMARY TIBIAL BEARING 18MM THICK X 79/83MM WIDE PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 002950

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R