BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

    MDR report key: 6545952 · Received May 4, 2017

    Report

    Report Number
    0001032347-2017-00354
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    November 17, 2017
    Report Date
    November 30, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK113512
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: OUTCOMES ATTRIBUTED TO ADVERSE EVENT, DATE OF EVENT, DATE OF THIS REPORT, DESCRIBE EVENT OR PROBLEM, UNIQUE IDENTIFIER (UDI) #, EXPLANT DATE, INITIAL REPORTER, DATE RECEIVED BY MANUFACTURER, TYPE OF REPORT AND FOLLOW-UP NUMBER, FOLLOW-UP TYPE, ADDITIONAL NARRATIVES/DATA. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00348-1, 0001032347-2017-00349-1, 0001032347-2017-00350-1, 0001032347-2017-00351-1, 0001032347-2017-00352-1, AND 0001032347-2017-00353-1.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE DEVICES REMAIN IMPLANTED, THEREFORE NO PRODUCT IS BEING RETURNED FOR EVALUATION. THE PATIENT'S DERMATOLOGIST STATES "THE PATIENT SEEMS TO HAVE A SEVERE REACTION TO THE IMPLANT." IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT A FOLLOW-UP REPORT WILL BE SENT. THIS IS REPORT SEVEN OF SEVEN FOR THE SAME EVENT, REFERENCE REPORTS 0001032347-2017-00348 THROUGH 0001032346-2017-00353.

    Additional Manufacturer Narrative · 1

    THESE PARTS WERE REMOVED IN A REVISION; THEREFORE, THE COMPLAINT IS CONSIDERED CONFIRMED. ALL EXTRACTED PARTS WERE RETURNED WITH THE EXCEPTION OF ONE PART #91-2708 AND ONE PART #91-2710. THESE MAY HAVE BEEN USED AND DISCARDED AS TWO EMERGENCY SCREWS WERE USED. MODERATE WEAR AND PATIENT TISSUE IS VISIBLE ON THE PARTS WHICH IS CONSISTENT WITH THE REPORT OF THESE PARTS BEING IMPLANTED AND EXPLANTED. THERE IS NO EVIDENCE OF ANY VISIBLE ANOMALIES OR DEFECTS. THE PATIENT STATED THAT THE REVISION WAS DUE TO ALLERGIC REACTION. HOWEVER, NO PHYSICIANS REPORTS OR TEST RESULTS WERE PROVIDED TO CONFIRM IF THE PATIENT WAS ALLERGIC TO THE IMPLANTS. BASED ON THE INFORMATION PROVIDED, THE CAUSE OF THE RASH AND HIVES COULD NOT BE DETERMINED. THERE IS NO EVIDENCE OF ANY VISIBLE ANOMALIES OR DEFECTS WITH THE RETURNED PRODUCT. FOR THESE REASONS, THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT COULD NOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE (IFU) FOR THIS PRODUCT PROVIDES SITUATIONS IN WHICH THESE IMPLANTS SHOULD NOT BE USED. IT STATES IN THE SECTION TITLED CONTRAINDICATIONS: 1. ACTIVE OR CHRONIC INFECTION. 3. SYSTEMIC DISEASE WITH INCREASED SUSCEPTIBILITY TO INFECTION 6. KNOWN ALLERGIC REACTION TO ANY MATERIALS USED IN THE COMPONENTS. NOTE: PATIENTS WITH KNOWN OR SUSPECTED NICKEL SENSITIVITY SHOULD NOT HAVE CO-CR-MO DEVICES IMPLANTED SINCE THIS MATERIAL CONTAINS NICKEL. 10. PATIENTS WITH A FOREIGN BODY REACTION DUE TO PREVIOUS IMPLANTS THE IFU ALSO STATES IN THE SECTION TITLED ADVERSE EVENTS: ADVERSE EVENTS THAT MAY OCCUR FOLLOWING PLACEMENT OF THE TOTAL TMJ REPLACEMENT SYSTEM ARE LISTED BELOW. SEE TABLES 7 AND 8 FOR MORE DETAILED INFORMATION ON ADVERSE EVENTS FROM THE CLINICAL TRIAL. ¿ REMOVAL OF COMPONENTS(S) INCLUDING, BUT NOT LIMITED TO THE FOLLOWING: - IMPLANT MATERIALS PRODUCING PARTICLES OR CORRODING ¿ INFECTION (SYSTEMIC OR SUPERFICIAL) ¿ FOREIGN BODY OR ALLERGIC REACTION TO IMPLANT COMPONENTS ¿ FOSSA WEAR THROUGH ¿ FACIAL SWELLING AND/OR PAIN THE MANUFACTURING HISTORY WAS REVIEWED FOR THE TMJ COMPONENTS AND REVIEWED AND NO DISCREPANCIES WERE FOUND. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. ROOT CAUSE WAS UNABLE TO BE DETERMINED. 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. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2017-00348-2, 0001032347-2017-00349-2, 0001032347-2017-00350-2, 0001032347-2017-00351-2, 0001032347-2017-00352-2, AND 0001032347-2017-00353-2.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HER IMPLANTS WERE REMOVED DUE TO AN ALLERGIC REACTION. SHE STATED THE JOINT WAS NOT REPLACED. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE DEVELOPED A RASH ON HER FACE AND NECK AND HIVES IN HER MOUTH ON THE SIDE OF HER TMJ IMPLANT. SHE STATED SHE IS ALLERGIC TO NICKEL AND IS ASKING FOR THE MATERIALS OF HER IMPLANT. SHE ALSO STATED HER DERMATOLOGIST PRESCRIBED BENADRYL, CLARITIN, ANTI-ITCHING MEDICATION, AND A EPINEPHRINE AUTO-INJECTOR (EPIPEN).

    Description of Event or Problem · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326587 BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES CROSS-DRIVE EMERGENCY SCREW 3.2X10MM HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R