BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC MOLDED TIBIAL COMPONENT

    MDR report key: 6766834 · Received August 4, 2017

    Report

    Report Number
    0001825034-2017-05837
    Event Type
    Injury
    Date Received
    August 4, 2017
    Date of Event
    July 21, 2014
    Report Date
    September 20, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). MICHAEL E. BEREND (2014) "USE OF SCREWS AND CEMENT IN REVISION TKA WITH PRIMARY OR REVISION SPECIFIC PROSTHESIS WITH UP TO 17 YEARS FOLLOWUP" THE JOURNAL OF ARTHROPLASTY, 30 (2015) 86-89 . COMMON DEVICE NAME - BIOMET PRODUCTS REPORTED IN THIS ARTICLE INCLUDE AGC, VANGUARD, MAXIM, BIOMET MOD TIB, VANGUARD SSK, BIOMET CCK, BIOMET ORTHOPAEDIC SALVAGE SYSTEM (OSS) AND AGC-CONSTRAINED HIGH POST. CONCOMITANT DEVICES ¿ UNKNOWN BIOMET FEMORAL COMPONENT CATALOG #: NI LOT #: NI, UNKNOWN BIOMET POLYETHYLENE BEARING CATALOG #: NI LOT #: NI. INITIAL CONTACT NAME ¿ THIS JOURNAL ARTICLE WAS WRITTEN BY MICHAEL E. BEREND, MERRILL A. RITTER, E. MICAEL KEATING, MICHAEL D. JACKSON, KENNETH E. DAVIS AND ROBERT A. MALINZAK. THE COMPLAINT DEVICE IS NOT EXPECTED FOR RETURN CURRENTLY, BUT A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. A COMPLAINT HISTORY REVIEW WAS UNABLE TO BE PERFORMED AS THE PART AND LOT NUMBERS ARE UNKNOWN. A ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THIS REPORT IS NUMBER 1 OF 3 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034-2017-05838 / 05839).

    Description of Event or Problem · 1

    IT IS REPORTED THAT ONE (1) PATIENT EXPERIENCED SUBLUXATION OF THE TIBIAL AND FEMORAL PROSTHESIS AND POLYETHYLENE WEAR EIGHT YEARS FOLLOWING KNEE ARTHROPLASTY. ATTEMPTS HAVE BEEN MADE TO RETRIEVE ADDITIONAL INFORMATION, BUT NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548977 UNKNOWN AGC MOLDED TIBIAL COMPONENT PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other