MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MM; PLATE, BONE

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (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: 0001032347-2020-00194, 0001032347-2020-00195, 0001032347-2020-00196.Medical products: tmj system left narrow mandibular component 50mm / 7 hole, part# 01-6551, lot# 723470a.Tmj system left fossa component, small, part# 24-6563, lot# 726780a.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Occupation: patient.

Event Description

It was reported by the patient that she underwent surgery to correct issues with her jaw following implantation of temporomandibular joint implants on the left side three (3) years ago.The patient also reports pain so severe that she can barely open her mouth.Attempts have been made but no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed, because an additional surgery was performed to fix the patient's reported jaw issues.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 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.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This report is being submitted to update additional information in section a3, b4, b5, e1, e2, e3, g3, g6, h2, h6 and h10.

Event Description

It is further reported that the patient has scar tissue against left joint replacement causing misalignment and creating a scissor bite.Her right side joint is being affected by compensation for the left side implant issues.No further intervention has been reported.

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.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.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 is available at the time of this report.

Event Description

It was further reported that the patient is being planned for a revision to a new custom implant.

• Brand Name: TMJ SYSTEM CROSS DRIVE FOSSA SCREW 2.0MM X 7MM
• Type of Device: PLATE, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 9920593
• MDR Text Key: 189458925
• Report Number: 0001032347-2020-00197
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 00841036057442
• UDI-Public: 00841036057442
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 99-6577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female