MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT MEDIUM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Swelling (2091); Blurred Vision (2137)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 because it remains implanted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00432, 0001032347-2019-00433, 0001032347-2019-00434, 0001032347-2019-00435, 0001032347-2019-00436, 0001032347-2019-00437.Concomitant medical products: tmj system left fossa component medium, part# 24-6561, lot# 602060a; tmj system right fossa component medium, part# 24-6560, lot# 739890a; tmj system left standard mandibular component, part# 24-6546, lot# 582360c; tmj system right standard mandibular component, part# 24-6545, lot# 759040a; tmj system cross drive fossa screw, part# 99-6577, lot# unk; "2.4mm" system high torque (ht) cross-drive screw, part# 91-2708, lot# unk; "2.44mm" system high torque (ht) cross-drive screw, part# 91-2710, lot# unk.Initial reporter ¿ patient.
Event or Problem Description
It was reported that the patient experienced facial swelling and blurry vision following the implantation of temporomandibular joints.The patient was prescribed celebrex and meloxicam to treat the facial swelling.No additional patient consequences were 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, pictures, or physician's reports were provided.The dhrs were reviewed for the fossa components.A nonconformance was opened for the right fossa to address pieces from this lot exceeding the action limit for dose audit testing, however, further investigation determined the parts to be safe for clinical use from a sterility standpoint.There are no indications of manufacturing defects.For all non-custom tmj fossa implants in the previous one year (from the notification date) involving squeaking or noises, there is a complaint rate of 1.03%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) involving a limited range of motion, there is a complaint rate of 0.56%, which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the complaint could not be determined.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 LEFT FOSSA COMPONENT MEDIUM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9173124
• Report Number: 0001032347-2019-00431
• Device Sequence Number: 16727630
• Product Code: LZD
• UDI-Device Identifier: 00841036036546
• UDI-Public: 00841036036546
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 01/29/2020

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: 24-6561
• Device Lot Number: 602060A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 01/21/2020
• Initial Report FDA Received Date: 10/09/2019
• Supplement Report FDA Received Date: 01/29/2020
• 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