BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ MED RTFOSSA COMP

    MDR report key: 3249539 · Received July 26, 2013

    Report

    Report Number
    0001032347-2013-00226
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    July 11, 2013
    Report Date
    July 15, 2013
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020116
    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. 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.

    Additional Manufacturer Narrative · 1

    BASED ON THE RECEIPT OF THE OPERATIVE RECORDS IT WAS CONFIRMED THE CAUSE OF THE EVENT IS THE FOSSA IMPLANT WAS FRACTURED DUE TO THE PATIENT SUSTAINING A BLOW TO THE RIGHT FACE. UPON EVALUATION, THE LINEAR NATURE OF THE FRACTURE BETWEEN THE FOSSA SCREW HOLES WAS CONSISTENT WITH A BLUNT FACIAL TRAUMA. MODERATE WEAR AND LIGHT SCRATCHING DESCRIBED ON THE ARTICULAR SURFACE MAY HAVE BEEN A RESULT OF NORMAL USAGE OF THE DEVICE FOR A PROLONGED TIME AND ARE NOT BELIEVED TO HAVE PLAYED A ROLE IN THE CAUSE OF FAILURE OF THIS DEVICE, ESPECIALLY IN ABSENCE OF COMPLAINTS BEFORE THE FACIAL TRAUMA. BASED ON THE AVAILABLE CLINICAL AND MECHANICAL DATA, THE PROBABLE CAUSES OF FAILURE WERE MATERIAL FAILURE DUE TO TRAUMA AND BIOLOGIC FAILURE DUE TO NEUROMA. CONTACT NAME AND E-MAIL WAS UPDATED. SUPPLEMENTAL REPORT ONE OF THREE FOR THE SAME EVENT, REFERENCE 1032347-2013-00227-1 AND 1032347-2013-00228-1.

    Description of Event or Problem · 1

    A REVISION SURGERY DUE TO A HISTORY OF TRAUMA AND PERSISTENT PAIN WAS REPORTED THROUGH THE BIOMET TMJ CLINICAL STUDY.

    Description of Event or Problem · 1

    THE OPERATIVE RECORDS WERE RECEIVED, INDICATING THE PROCEDURES PERFORMED WERE 1. OPEN ARTHROPLASTY, RIGHT MANDIBULAR JOINT. 2. EXCISION OF NEUROMA TISSUE. 3. REMOVAL OF DEEP BURIED IMPLANT. IT IS REPORTED THE PATIENT DID WELL AND WAS STABLE FOR APPROXIMATELY 8 YEARS AND THEN SUSTAINED A BLOW TO THE RIGHT FACE. SUBSEQUENT TO THE TRAUMATIC EVENT, SHE BEGAN HAVING PREAURICULAR SWELLING PAIN AND DIFFICULTY OPENING. THE PATIENT WAS TREATED CONSERVATIVELY WITH MEDICAL MANAGEMENT AND EPISODIC STEROIDS. UPON DISSECTION DURING THE REVISION SURGERY IT WAS IDENTIFIED THERE WAS A FRACTURE LINE ALONG THE LATERAL FLANGE OF THE IMPLANT ITSELF AND ALTHOUGH THE 3 SCREWS WERE STILL SECURE IN BONE, THE LOWER AND LARGER PORTION OF THE IMPLANT HAD MOBILITY AS IT WAS NO LONGER CONNECTED TO ALL 3 OF THE 2.0MM SCREWS. THE IMPLANT WAS IRREPARABLE AND THEREFORE WAS REMOVED. NO VISIBLE POLYETHYLENE DEBRIS WAS NOTED. THE INTRA-OP ASSESSMENT ALSO SHOWED HEAVY SCAR TISSUE AND INTERPOSITIONAL TISSUE BETWEEN THE CONDYLAR HEAD AND THE FOSSA. THE SURGEON DECIDED NOT TO REINSERT ANOTHER FOSSA IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351658 TMJ MED RTFOSSA COMP FOSSA IMPLANT LZD BIOMET MICROFIXATION N/A 381620

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Hospitalization