BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DCM MAXIM PRIMARY TIBIAL BEARING

    MDR report key: 7165859 · Received January 4, 2018

    Report

    Report Number
    0001825034-2018-00070
    Event Type
    Injury
    Date Received
    January 4, 2018
    Date of Event
    December 6, 2017
    Report Date
    January 18, 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
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BMET ARCOM AP PAT W/WIRE 34MM CAT#: 11-150828, LOT#: 531890 , MAXIM POR ANA PRI FML 65 RT CAT#: 140052, LOT#: 042760 , BIOMET CC CRUCIATE TRAY 63MM CAT#: 141231, LOT#: 914070. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT HAS BEEN DISCARDED. 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. PRODUCT HAS BEEN DISCARDED.

    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. DHR WAS REVIEWED AND NO DISCREPANCIES 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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED SEVENTEEN YEARS AFTER INITIAL KNEE PROCEDURE DUE TO ARTICULAR SURFACE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8207 DCM MAXIM PRIMARY TIBIAL BEARING PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 856420

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R