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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pain (1994); Discomfort (2330); Sensitivity of Teeth (2427); Difficulty Chewing (2670)

Event Type  Injury  

Manufacturer Narrative

(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: 0001032347-2019-00484, 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.Occupation: patient.

Event 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.

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.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.

• Brand Name: TMJ SYSTEM LEFT STANDARD TITANIUM MANDIBULAR COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9295891
• MDR Text Key: 165616940
• Report Number: 0001032347-2019-00483
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036081737
• UDI-Public: 00841036081737
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-6551TI
• Device Lot Number: 569860B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/10/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention