BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEMPOROMANDIBULAR JOINT SMALL RIGHT FOSSA COMPONENT

    MDR report key: 2747861 · Received September 18, 2012

    Report

    Report Number
    0001032347-2012-00114
    Event Type
    Injury
    Date Received
    September 18, 2012
    Date of Event
    August 27, 2012
    Report Date
    August 28, 2012
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED AND ANALYZED AS PART OF THE (B)(6) STUDY. THIS SUPPLEMENTAL REPORT IS LATE INFORMATION RECEIVED FROM THE (B)(4), WHICH WAS REPORTED AS EXPECTED TO THE PS STUDIES PROGRAM, BUT INADVERTENTLY NOT RECOGNIZED AS 803 REPORTABLE UNTIL AFTER THE CLOSE OF THE STUDY. ACCORDING TO THE STUDY: NO FAILURE MODE WAS IDENTIFIED. ADDITIONALLY, HETEROTOPIC BONE FORMATION WAS CONFIRMED. BONE GROWTH AROUND THE IMPLANT CAUSED RE-ANKYLOSIS OF THE JOINT. THIS PATIENT ALSO HAS PREVIOUS HISTORY OF ANKYLOSIS, WHICH LED TO THE ORIGINAL IMPLANTATION OF AN ALLOPLASTIC TMJ DEVICE, THE REVISION OF THAT DEVICE AND THE REVISION OF THE BIOMET TMJ REPLACEMENT DEVICE. THIS IS REPORT 2 OF 2 FOR THE SAME EVENT. REPORT 1 OF 2 IS REPORTED ON MFR #0001032347-2012-00113-1.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE RETURNED PRODUCT WAS EVALUATED AND NO NON-CONFORMANCES WERE IDENTIFIED. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A REVISION SURGERY DUE TO THE SCREWS BACKING OUT OF THE TMJ COMPONENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TEMPOROMANDIBULAR JOINT SMALL RIGHT FOSSA COMPONENT FOSSA IMPLANT LZD BIOMET MICROFIXATION N/A 212910

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization| R