BEUDAMED
    FDA Adverse Event Other Summary report: N

    TMJ TOTAL JOINT REPLACEMENT PROSTHESIS SYSTEM

    MDR report key: 3338290 · Received August 27, 2013

    Report

    Report Number
    3009702671-2013-00001
    Event Type
    Other
    Date Received
    August 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    August 26, 2013
    Manufacturer
    TMJ MEDICAL LLC
    Product Code
    LZD
    PMA / PMN Number
    000023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TMJ MEDICAL REQUESTED THAT THE EXPLANTING SURGEON RETURN THE EXPLANTED DEVICE TO TMJ MEDICAL LLC. HOWEVER, THE REQUEST COULD NOT BE PROCESSED THROUGH THE HOSPITAL'S LEGAL DEPARTMENT BEFORE THE LABORATORY DISPOSED OF THE EXPLANTED DEVICE. THE LABORATORY DISPOSES OF ALL EXPLANTED DEVICES AFTER ONE WEEK UNLESS INSTRUCTED OTHERWISE. ADDITIONAL INFORMATION: MODEL #: 500092, CATALOG #: 500092, SERIAL #: (B)(4), LOT #: 15198, EXPIRATION DATE: 09/01/2017. ADDITIONAL MANUFACTURE DATE: 09/01/2012.

    Description of Event or Problem · 1

    PATIENT RECEIVED RIGHT TOTAL JOINT REPLACEMENT ON (B)(6) 2013. TWO WEEKS AFTER IMPLANTATION PATIENT DEVELOPED SWELLING AND PAIN. PATIENT WAS UNRESPONSIVE TO ANTIBIOTICS. ON (B)(6) 2013 SURGICAL PROCEDURE OF DEBRIDEMENT AND IRRIGATION OF RIGHT TEMPOROMANDIBULAR JOINT PROSTHESIS PERFORMED. DURING SURGERY, THE PROSTHESIS WAS UNCOVERED AND FOUND TO HAVE NORMAL APPEARING GRANULATION TISSUE. SYMPTOMS CONTINUED AND IMPLANTS WERE EXPLANTED ON (B)(6) 2013 DUE TO CONTINUING PAIN AND SWELLING OF THE RIGHT TEMPOROMANDIBULAR JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418214 TMJ TOTAL JOINT REPLACEMENT PROSTHESIS SYSTEM LZD TMJ MEDICAL LLC 500074 15135

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| O| R