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

Model Number N/A

Device Problem Noise, Audible (3273)

Patient Problems Dysphagia/ Odynophagia (1815); Headache (1880); Pain (1994); Dysphasia (2195); Difficulty Chewing (2670); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

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 left narrow mandibular component, catalog #: 01-6545 lot # 457410b; 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: 0001032347-2019-00304, 0001032347-2019-00305, and 0001032347-2019-00306.

Event 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.

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, 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.

• Brand Name: TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT, 45 MM
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8642623
• MDR Text Key: 146204780
• Report Number: 0001032347-2019-00303
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036011857
• UDI-Public: 00841036011857
• 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: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2013
• Device Model Number: N/A
• Device Catalogue Number: 01-6545
• Device Lot Number: 457410B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention