BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SMALL LEFT FOSSA COMPONENT

    MDR report key: 1821641 · Received August 31, 2010

    Report

    Report Number
    1032347-2010-00147
    Event Type
    Injury
    Date Received
    August 31, 2010
    Report Date
    July 9, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    P020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE THE PRODUCT WAS EXPLANTED WAS NOT KNOWN, IT OCCURRED SOMETIME IN (B)(6) 2008 BY DR.(B)(6) (WHO IS NOW DECEASED). DR. (B)(6) REPORTED THE EVENT. 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. THIS PATIENT HAD A BI-LATERAL TMJ REPLACEMENT, AND BOTH FOSSA COMPONENTS WERE EXPLANTED DURING THE REVISION SURGERY. SEE MDR 1032347-2010-00147 & 148.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED AS PART OF THE (B)(6) STUDY. THIS IS LATE INFORMATION RECEIVED FROM THE (B)(6) STUDY, WHICH WAS REPORTED AS EXPECTED TO THE (B)(6) STUDIES PROGRAM, BUT INADVERTENTLY NOT RECOGNIZED AS 803 REPORTABLE UNTIL AFTER THE CLOSE OF THE STUDY. NO MODE OF FAILURE WAS IDENTIFIED FOR THIS DEVICE. CLINICAL INFORMATION AVAILABLE CONFIRMS THAT PATIENT SOUGHT MEDICAL CARE DUE TO PERSISTENT PAIN AND SWELLING LEADING TO A REVISION SURGERY AND REMOVAL OF THE FOSSA COMPONENT WITHOUT ANY OTHER CONFIRMED BIOLOGICAL INDICATION FOR EXPLANTATION OF THE DEVICE. REPORT ONE OF TWO FOR THE SAME EVENT, REFERENCE 1032347-2010-00148-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD SWELLING, THEREFORE THE DOCTOR DECIDED TO REMOVE THE FOSSA IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TMJ SMALL LEFT FOSSA COMPONENT TMJ LZD BIOMET MICROFIXATION 167020

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization