BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET CC CRUCIATE TRAY 67MM

    MDR report key: 6326523 · Received February 13, 2017

    Report

    Report Number
    0001825034-2017-00566
    Event Type
    Injury
    Date Received
    February 13, 2017
    Date of Event
    January 24, 2017
    Report Date
    October 6, 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
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT. THIS IS 4 OF 4 REPORTS BEING FILED FOR THE SAME PATIENT (REFERENCE 1825034-2017-00563 - 00566).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCT - MAXIM POR ANA PRI FML 60 RT CATALOG# 140051 LOT# 153780 , BMET ARCOM AP PAT W/WIRE 31MM CATALOG# 11-150826 LOT# 264970 , PALACOS BONE CEMENT 40GRAM CATALOG# 424800 LOT# 003236 , MAX PRI DCM TIB BRNG10X63/67MM CATALOG# 11-146130 LOT# 989460 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 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 IS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING APPROXIMATELY 16 YEARS POST-IMPLANTATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT WAS REVISED ON THE RIGHT KNEE DUE TO LOOSENING APPROXIMATELY 16 YEARS POST-IMPLANTATION. THE COMPONENTS WERE REMOVED AND REPLACED WITH COMPETITOR PRODUCTS EXCEPT THE TIBIAL CONE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107946 BIOMET CC CRUCIATE TRAY 67MM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 294670

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R