MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT 50 MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

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

Patient Problems Nerve Damage (1979); Loss of Range of Motion (2032); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device will not be returned for analysis as it remains implanted; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00039.Concomitant medical products: tmj system right fossa component, small, part# 24-6562, lot# 642760a.Unknown mandible screw, part# ni, lot# ni.Unknown fossa screw, part# ni, lot# ni.Initial reporter ¿patient.

Event Description

It was reported the patient has experienced various issues five (5) years following implantation of temporomandibular joint implants on the right side.Immediately following implantation, the patient could not raise their right eyebrow.The patient underwent eight (8) weeks of physical therapy within two (2) years of implantation and the patient could open the right side of their mouth almost as well as the left side.Five (5) years following implantation, the patient reported they are unable to open their mouth the same as it was, their right eye droops and their right eyebrow does not go up like it should.The patient reported they are able to open their mouth to eat.The patient indicated that they are satisfied with the results of their device, and will return to their surgeon should their symptoms worsen.It was reported that no further information is available.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot 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.

Event Description

No further event information available at the time of this report.

• Brand Name: TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT 50 MM / 7 HOLE
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11263152
• MDR Text Key: 230219872
• Report Number: 0001032347-2021-00040
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036011895
• UDI-Public: (01)00841036011895(17)200617(10)608270
• 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: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2020
• Device Model Number: N/A
• Device Catalogue Number: 01-6550
• Device Lot Number: 608270B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other