BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET SERIES A STANDARD PATELLA 31MM X 8.0MM

    MDR report key: 7970519 · Received October 16, 2018

    Report

    Report Number
    0001825034-2018-09750
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    January 2, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. 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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

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

    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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT DEVICES: BIOMET CC CRUCIATE TIBIAL TRAY 71MM, CATALOG #: 141233, LOT #: J2476418. VANGUARD CRUCIATE RETAINING INTERLOK FEMORAL COMPONENT RIGHT 62.5MM, CATALOG #: 183006, LOT #: 899250. 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, 0001825034-2018-09751.

    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. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810679 BIOMET SERIES A STANDARD PATELLA 31MM X 8.0MM PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 680570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R