BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET COBALT CHROMIUM CRUCIATE TRAY

    MDR report key: 6960831 · Received October 19, 2017

    Report

    Report Number
    0001825034-2017-08816
    Event Type
    Injury
    Date Received
    October 19, 2017
    Report Date
    January 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS - VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT RIGHT 62.5MM CATALOG #: 183006 LOT #: 899250, BIOMET SERIES A STANDARD PATELLA 31MM X 8.0MM CATALOG #: 184764 LOT #: 680570, VANGUARD DCM CRUCIATE RETAINING TIBIAL BEARING 10MM X 71/75MM CATALOG #: 183440 LOT #: 810730. THE PRODUCT WAS EVALUATED THROUGH MANUFACTURING REVIEW, HOWEVER, THE REPORTED EVENT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND NO DISCREPANCIES WERE 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS PATIENT; PLEASE SEE ALL REPORTS ASSOCIATED WITH THIS EVENT: 0001825034-2017-08816, 0001825034-2017-08817, 0001825034-2018-09750, 0001825034-2018-09751.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, POTENTIAL METAL POISONING AND CROOKEDNESS OF THE LEG FOLLOWING RIGHT KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCT: VANGUARD CRUCIATE RETAINING ILOK FEMORAL, CAT#: 183006, LOT#: 899250. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-08817. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. A ROOT CAUSE REMAINS UNDETERMINED. 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 IS EXPERIENCING PAIN AND POSSIBLE METAL POISONING. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, POTENTIAL METAL POISONING AND CROOKEDNESS OF THE LEG FOLLOWING RIGHT KNEE ARTHROPLASTY. THE PATIENT STATED THAT IMMEDIATELY AFTER THE PROCEDURE, THE KNEE APPEARED TO HAVE SHIFTED AND THE PATIENT CAN HARDLY WALK AND HAS NOW SINCE HAD TO USE A WALKER. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Description of Event or Problem · 1

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742612 BIOMET COBALT CHROMIUM CRUCIATE TRAY PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A J2476418

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R