MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT NARROW TITANIUM MANDIBULAR COMPONENT 45 MM / 6 HOLE TI-6AL-4V AL; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Material Protrusion/Extrusion (2979); Positioning Problem (3009)

Patient Problems Headache (1880); Pain (1994); Seizures (2063); Blurred Vision (2137); Irritability (2421)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: biomet microfixation tmj sm lft fossa comp, catalog #: 24-6563, lot #: 822060a; unknown.Biomet microfixation screws (potential), catalog #: 91-2710, 99-6577, and 99-6579.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: 0001032347-2019-00285.

Event Description

It was reported that the patient has been experiencing several neurological symptoms since her tmj replacement surgery approximately four months ago.The patient reports that one of the screws was placed too far and it is hitting her brain with symptoms including: smelling weird things, having deja vu, trouble remembering what she is going to say, headaches, double vision in the left eye and irritability and seizures.The patient was referred to a neurologist after mentioning the headaches and reports the neurologist suggested removing the screw and replacing it with a smaller one.Attempts have been made and no further information has been provided.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.Because there was a revision surgery reported, the complaint is considered to be confirmed.The complaint was opened because the patient reported: "they went too far with one of the screws and it is hitting my brain." she stated the screw is actually tickling her brain and causing headaches, double vision, deja vu, seizures, nerve pain, and she smells weird things.No product was returned, therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.It was reported that one of the screws was inserted too far, which led to the symptoms described above.It was also reported that the screw was removed in june 2019 and replaced with another screw.The dhr for the mandible component was reviewed, no non-conformances were found.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding the screw being too long or improper placement, there is a complaint rate of 0.15%, which is no greater than the occurrence listed in the afmea.Due to the lack of x-rays, scans, physician's reports, and details regarding the explanted screw and replacement screw, the most likely underlying cause of the complaint could not be determined.It is possible that the originally implanted screw was not sized properly.There are no indications of manufacturing defects.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.The following fields were updated: b4 date of this report b5 describe event or problem d10 device availability g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: TMJ SYSTEM LEFT NARROW TITANIUM MANDIBULAR COMPONENT 45 MM / 6 HOLE TI-6AL-4V AL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8623348
• MDR Text Key: 145487017
• Report Number: 0001032347-2019-00286
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036081782
• UDI-Public: 00841036081782
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2023
• Device Model Number: N/A
• Device Catalogue Number: 01-6546TI
• Device Lot Number: 855250B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/20/2019
• Initial Date FDA Received: 05/20/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention