MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); Discomfort (2330); Sensitivity of Teeth (2427); Difficulty Chewing (2670)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00483, 0001032347-2019-00484, 0001032347-2019-00485, 0001032347-2019-00486.Concomitant medical products: tmj system left standard titanium mandibular component, part# 24-6551ti, lot# 569860b; tmj system left fossa component, small, part# 24-6563, lot# 721310a; tmj system right standard titanium mandibular component, part# 24-6545ti, lot# 703580a; tmj system right fossa component, small, part# 24-6562, lot# 721330b.
Event or Problem Description
It was reported the patient is experiencing pain, neuralgia, and loss of function in the right joint following the implantation of bilateral temporomandibular joint prostheses.The patient has braces that are adjusted every three months to compensate for malocclusion.The patient has bilateral tooth pain and cannot chew on the right side.The patient sees their general practitioner dentist every three months and the dentist recommends the removal of the temporomandibular joint prostheses.The oral surgeon recommends allergy testing which the patient has declined.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, or pictures were provided.The non-conformance database was reviewed for the mandibular components and no non-conformances were found.For all non-custom tmj mandibular implants in the previous one year (from the notification date) involving pain, there is a complaint rate of 1.90%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) involving nerve damage, there is a complaint rate of 0.37%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding malocclusion, there is a complaint rate of 0.260%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) involving trouble with mastication, there is a complaint rate of 0.446%, which is no greater than the occurrence listed in the afmea.The complaints database was searched for each part & lot number listed in this complaint file.This was the only complaint of pain, nerve damage, limited range of motion, or malocclusion for each of the mandibular and fossa components listed in this complaint.The most likely underlying cause of the complaint is the patient's condition of condylar hyperplasia.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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9295989
• Report Number: 0001032347-2019-00485
• Device Sequence Number: 410088
• Product Code: LZD
• UDI-Device Identifier: 00841036075118
• UDI-Public: 00841036075118
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2020

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-6545TI
• Device Lot Number: 703580A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 03/10/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention