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

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Sleep Dysfunction (2517); 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.The device will not be returned for evaluation as it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00444, 0001032347-2019-00445, 0001032347-2019-00446, 0001032347-2019-00448, 0001032347-2019-00449, 0001032347-2019-00450, 0001032347-2019-00451, 0001032347-2019-00452, 0001032347-2019-00453, 0001032347-2019-00454.Concomitant medical products: tmj system left fossa component small, cat# 24-6563, lot# 761290a; tmj system right fossa component small, cat# 24-6562, lot# 783330b; tmj system left standard mandibular component, cat# 24-6551, lot# 751050c; tmj system right standard mandibular component, cat# 24-6550, lot# 759080a; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "2.44mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; traumaone system 2.0x7mm self-drilling imf screw, cat# 91-5607, lot# unk; traumaone system 2.0x9mm self-drilling imf screw, cat# 91-5609, lot# unk; tmj system cross drive fossa screw, cat# 99-6577, lot# unk; tmj system cross drive emergency fossa screw, cat# 99-6587, lot# unk; "2.7mm" system emergency cross drive screw 1/pkg, cat# 99-9948, lot# unk.Occupation: patient.
Event or Problem Description
It was reported the patient underwent a medical intervention to treat pain associated with their temporomandibular implants.The patient has facial pain that causes difficulty eating and sleeping.The patient has received botox injections and is currently prescribed lyrica, amitriptyline, and tramadol to treat pain and sleeplessness associated with pain.No additional patient consequences have been reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
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, pictures, or physician's reports were provided.The dhrs for the mandible components were reviewed, no non-conformances were found.There are no indications of manufacturing defects.For all non-custom tmj mandibular implants in the previous one year (from the notification date) involving pain, there is a complaint rate of (b)(4), 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 noises, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the afmea.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: date of this report, describe event or problem, device availability, date received by manufacturer, type of report, follow up type, device evaluated by manufacturer, method code, results,conclusions code, additional narratives/data.

• Brand Name: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9177298
• Report Number: 0001032347-2019-00447
• Device Sequence Number: 2591410
• Product Code: LZD
• UDI-Device Identifier: 00841036060343
• UDI-Public: 00841036060343
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/30/2020

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: 24-6550
• Device Lot Number: 759080A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 01/22/2020
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention