MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT, 45 MM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Noise, Audible (3273)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Headache (1880); Pain (1994); Dysphasia (2195); Difficulty Chewing (2670); Limited Mobility Of The Implanted Joint (2671)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product - zimmer biomet tmj system left fossa component, small catalog #: 24-6563 lot # 527660b.Zimmer biomet tmj system right fossa component, small catalog #: 24-6562 lot # 472630a.Zimmer biomet tmj system right narrow mandibular component catalog #: 01-6546 lot # 532890a.Zimmer biomet 2.7x8mm screw catalog #: 91-2708 lot # ni.Zimmer biomet 2.7x10mm screw catalog #: 91-2710 lot # ni.Zimmer biomet 2.0x7mm screw catalog #: 99-6577 lot # ni multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00303, 0001032347-2019-00305, and 0001032347-2019-00306.
Event or Problem Description
It was reported that the patient is experiencing speech difficulty, pain, issues with opening her mouth and chewing, gagging when eating, migraines, and squeaking in her joint.The patient has received botox injections to treat her symptoms.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 severity of this complaint is no greater than the severity listed in the fmea.The most likely underlying cause of the complaint cannot be determined.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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT, 45 MM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8642617
• Report Number: 0001032347-2019-00304
• Device Sequence Number: 13925380
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: 00841036011871
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2019

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 06/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 532890A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 08/14/2019
• Initial Report FDA Received Date: 05/24/2019
• Supplement Report FDA Received Date: 08/19/2019
• 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