BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TMJ SYSTEM LEFT FOSSA COMPONENT SMALL

    MDR report key: 7248175 · Received February 7, 2018

    Report

    Report Number
    0001032347-2018-00064
    Event Type
    Injury
    Date Received
    February 7, 2018
    Report Date
    June 14, 2018
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    LZD
    PMA / PMN Number
    PP020016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE COMPLAINT IS CONSIDERED CONFIRMED BASED ON THE INFORMATION PROVIDED. VISUAL INSPECTION AND FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE PRODUCTS REMAINING IMPLANTED. THE COMPLAINT THAT THE PATIENT IS EXPERIENCING PAIN IS CONSIDERED CONFIRMED AS SHE REPORTED THAT HER FAMILY PRACTICE DOCTOR WHO LIKELY EVALUATES HER ON A CONSISTENT BASIS HAS BEEN PRESCRIBING HER MEDICATIONS FOR PAIN CONTROL. PRIOR TO THIS, SHE HAD BEEN SEEING ANOTHER PHYSICIAN FOR CORTISONE AND BOTOX INJECTIONS, THOUGH THESE WERE ULTIMATELY DISCONTINUED DUE TO THE CONCERN THAT THERE WERE NOT ENOUGH STUDIES DONE ON WHETHER THE INJECTIONS CAN CAUSE DAMAGE TO THE JOINT OR CAUSE INFECTIONS. SHE REPORTED THAT SHE HAD A FALL ONE TO TWO YEARS AGO, HAD FOLLOW UP IMAGING AND WAS ADVISED BY THE DOCTOR THAT NONE OF THE HARDWARE HAD LOOSENED. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE PATIENT COMPLAINED THAT HER JAW "FEELS VERY TIGHT" AND SHE ALSO REPORTED THAT SHE HAS TROUBLE OPENING HER MOUTH, BOTH OF WHICH INDICATE SHE IS EXPERIENCING LIMITED RANGE OF MOTION. MEANWHILE, SHE ALSO HAD REPORTED THAT SHE HAS TROUBLE CHEWING AND DEVELOPED SOME "LIP DROOPING", WHICH INDICATE SHE IS EXPERIENCING TROUBLE WITH MASTICATION. THE PRODUCTS HAVE NOT BEEN RETURNED AND NO ADDITIONAL MATERIALS IN THE FORM OF PHOTOGRAPHS, X-RAYS, SCANS, OR PHYSICIAN REPORTS HAVE BEEN PROVIDED TO SUBSTANTIATE THIS COMPLAINT; THEREFORE, THE COMPLAINT CANNOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED. THE COMPLAINT THAT THE PATIENT'S EYE "STAYED SHUT FOR A MONTH" IS LIKELY UNRELATED TO THE IMPLANT DUE TO ANATOMICAL LOCATION; THERE HAVE BEEN NO PHOTOGRAPHS, X-RAYS, SCANS, OR PHYSICIAN REPORTS PROVIDED TO SUBSTANTIATE THIS COMPLAINT; THEREFORE IT CANNOT BE VERIFIED AND THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED. THE COMPLAINT THAT THE "JOINT STICKS OUT" INDICATES THAT THE IMPLANT NO LONGER FITS PROPERLY (COULD BE RELATED TO IMPLANT SIZE OR ALIGNMENT WHICH COULD RESULT IN MALOCCLUSION) AND/OR MAY HAVE DISLOCATED. HOWEVER, THIS CANNOT BE VERIFIED BECAUSE NO ADDITIONAL INFORMATION IN THE FORM OF PHOTOGRAPHS, X-RAYS, SCANS, OR PHYSICIAN REPORTS HAVE BEEN PROVIDED TO SUBSTANTIATE THIS COMPLAINT. THE MOST LIKELY UNDERLYING CAUSE CANNOT BE DETERMINED. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED FOR THE SCREWS AS THE LOT NUMBERS OF THE DEVICES INVOLVED IN THE EVENT ARE UNKNOWN. THE MANUFACTURING HISTORY WAS REVIEWED FOR THE TMJ IMPLANTS AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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: 0001032347-2018-00061-2 THROUGH 0001032347-2018-00069-2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00061-1 THROUGH 0001032347-2018-00069-1.

    Description of Event or Problem · 0

    UPON FOLLOW UP THE PATIENT REPORTS SHE RECEIVED HER LAST INJECTIONS FOR THE YEAR ON HER LEFT SIDE. HER PAIN TODAY WAS IN THE "BALL JOINT" PART BY THE EAR. SHE STILL HAS TROUBLE CHEWING. SHE ALSO STATES, NOW, DOING THE EXERCISES HELPS TO IMPROVE HER OPENING AND CHEWING. HER RIGHT SIDE IS STARTING TO HAVE ISSUES WITH THE NERVES. WHEN SHE BENDS DOWN TOO QUICKLY (I.E. PETTING A DOG OR DRYING HER HAIR) SHE FEELS A PAIN THROUGH HER LEFT JAW. HER FAMILY PRACTICE DOCTOR PRESCRIBES TWO NARCOTICS A DAY AND IBUPROFEN FOR THE PAIN.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THEY REMAIN IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCT: BIOMET MICROFIXATION TMJ LEFT NARROW MANDIBLE CATALOG #: 01-6551 LOT #: 190780, BIOMET MICROFIXATION TMJ RIGHT NARROW MANDIBLE CATALOG #: 01-6550 LOT #: 299210, BIOMET MICROFIXATION SMALL RIGHT FOSSA CATALOG #: 24-6562 LOT #: 328400, BIOMET MICROFIXATION 2.7 X 8 MM HT CROSS-DRIVE SCREW CATALOG #: 91-2708 LOT # NI, BIOMET MICROFIXATION 2.7 X 10 MM HT CROSS-DRIVE SCREW CATALOG #: 91-2710 LOT # NI, BIOMET MICROFIXATION CROSS DRIVE FOSSA SCREW 2.0 MM X 7 MM CATALOG #: 99-6577 LOT # NI, BIOMET MICROFIXATION CROSS DRIVE FOSSA SCREW 2.0 MM X 9 MM CATALOG #: 99-6579 LOT # NI, BIOMET MICROFIXATION CROSS DRIVE FOSSA SCREW 2.0 MM X 11 MM CATALOG #: 99-6581 LOT # NI. THERAPY DATE: UNKNOWN. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001032347-2018-00061 THROUGH 0001032347-2018-00069.

    Description of Event or Problem · 1

    THE PATIENT REPORTED SHE HAS BEEN HAVING PAIN IN HER LEFT JOINT AND THAT THE JOINT STICKS OUT; ALSO HER JAW FEELS VERY TIGHT AND AFTER MUCH TALKING SHE'S GOT TO STOP BECAUSE IT HURTS. SHE HAS BEEN GETTING CORTISONE AND BOTOX SHOTS. THE SURGEON IS HESITANT ABOUT CONTINUING THE INJECTIONS AND SAID HE COULD REMOVE THE JOINTS, HOWEVER THE PATIENT DOES NOT WANT TO UNDERGO ANOTHER SURGERY. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91734 TMJ SYSTEM LEFT FOSSA COMPONENT SMALL JOINT, TEMPOROMANDIBULAR, IMPLANT LZD BIOMET MICROFIXATION N/A 316400

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention