BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

    MDR report key: 4973877 · Received August 5, 2015

    Report

    Report Number
    0001032347-2015-00339
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 1, 2015
    Report Date
    August 12, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT. REPORT TWO OF FOUR FOR THE SAME EVENT, SEE ALSO 1032347-2015-00338, 1032347-2015-00340 AND 1032347-2015-00341.

    Additional Manufacturer Narrative · 1

    THE RETURNED TMJ PARTS WERE EVALUATED FOR THE COMPLAINT OF A REVISION DUE TO HETEROTOPIC BONE GROWTH. THE PARTS WERE VISUALLY INSPECTED AND FOUND IN GOOD WORKING CONDITION. THE PARTS SHOW NO SIGNS OF MANUFACTURING DEFECTS AND NO MALFUNCTION WAS REPORTED. THE COMPLAINT CANNOT BE VERIFIED AS THE PARTS WERE FOUND IN WORKING CONDITION AND EXPLANTED DUE TO THE PATIENTS CONDITION OF HETEROTOPIC BONE GROWTH. THE IFU (INSTRUCTIONS FOR USE) WARNS OF HETEROTOPIC BONE GROWTH AS AN ADVERSE EVENT FOR THIS SURGERY. THE MOST LIKELY CAUSE OF THE COMPLAINT IS PATIENTS CONDITION. THE DEVICE EVALUATION IDENTIFIED TWO ADDITIONAL SCREW PART NUMBERS, SEE REPORTS 1032347-2016-00051 AND 1032347-2016-00052. SUPPLEMENTAL REPORT TWO OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2015-00338-3, 1032347-2015-00340-3 AND 1032347-2015-00341-3. FIELDS WERE UPDATED BASED ON THE COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    UPDATED BASED ON THE RECEIPT OF ADDITIONAL INFORMATION REGARDING THE REASON FOR THE REVISION. SUPPLEMENTAL REPORT TWO OF FOUR FOR THE SAME EVENT, SEE ALSO 1032347-2015-00338-1, 1032347-2015-00340-1, AND 1032347-2015-00341-1.

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.SUPPLEMENTAL REPORT TWO OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2015-00338-2, 1032347-2015-00340-2 AND 1032347-2015-00341-2.

    Description of Event or Problem · 1

    A TMJ REVISION SURGERY WAS IDENTIFIED THROUGH THE RECEIPT OF TMJ TRACKING CARDS. ON (B)(6) 2010 A BIOMET JOINT WAS IMPLANTED ON THE LEFT SIDE ONLY. IT IS REPORTED THE PATIENT WAS EXPERIENCING SOME DISCOMFORT, THEREFORE A REVISION SURGERY WAS PERFORMED ON (B)(6) 2015 AND THE JOINT WAS REPLACED WITH A NEW BIOMET JOINT.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE CONFIRMED THE REASON FOR THE REVISION WAS DUE TO HETEROTOPIC BONE GROWTH. AFTER THE BONE WAS REMOVED THE SURGEON WAS ABLE TO IMPLANT A NEW PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512250 TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM TMJ LEFT MANDIBLE LZD BIOMET MICROFIXATION N/A 205870A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R