BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT

    MDR report key: 7370420 · Received March 26, 2018

    Report

    Report Number
    0001032347-2018-00143
    Event Type
    Injury
    Date Received
    March 26, 2018
    Date of Event
    July 1, 2017
    Report Date
    August 31, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE PATIENT REPORTED THAT THESE PARTS WERE REMOVED IN A REVISION; THEREFORE THE COMPLAINT IS CONSIDERED CONFIRMED. NO PRODUCT WAS RETURNED AND NO FUNCTIONAL TESTS OR INSPECTIONS COULD BE PERFORMED. NO X-RAYS, SCANS, PICTURES, OR PHYSICIANS REPORTS WERE PROVIDED. NO ADDITIONAL DETAILS COULD BE GATHERED. DEVICE HISTORY RECORD (DHR) WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT HAS THE FOLLOWING INFORMATION IN THE SECTION TITLED ADVERSE EVENTS ADVERSE EVENTS THAT MAY OCCUR FOLLOWING PLACEMENT OF THE TOTAL TMJ REPLACEMENT SYSTEM ARE LISTED BELOW: REMOVAL OF COMPONENTS(S) INCLUDING, BUT NOT LIMITED TO THE FOLLOWING: IMPLANT CHANGES CAUSED BY LOADING AND/OR WEAR DEGENERATIVE CHANGES WITHIN THE JOINT SURFACES FROM DISEASE OR PREVIOUS IMPLANTS. IMPLANT MATERIALS PRODUCING PARTICLES OR CORRODING. INFECTION (SYSTEMIC OR SUPERFICIAL). IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. DEVICE EVALUATED BY MANUFACTURER AND NOT RETURNED TO MANUFACTURER. (B)(4). MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00144-1, 0001032347-2018-001445-1, AND 0001032347-2018-00146-1.

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT (B)(4). DATE OF EVENT, EXPLANT DATE, AND THERAPY DATE: THE PATIENT STATES HER IMPLANTS WERE EXPLANTED IN (B)(6) 2017, THE DAY IS UNKNOWN. CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION SMALL RIGHT FOSSA COMPONENT, CATALOG #: 24-6562, LOT #: 697960B; BIOMET MICROFIXATION CROSS DRIVE FOSSA SCREW, CATALOG #: 99-6577, LOT #: NI; BIOMET MICROFIXATION HT CROSS-DRIVE SCREW, CATALOG #: 91-2710, LOT #: NI. THERAPY DATE: JULY 1, 2017. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00144, 0001032347-2018-001445, AND 0001032347-2018-00146.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT HER RIGHT IMPLANTS WERE REMOVED DUE TO AN INFECTION. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213226 TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 578300B

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R