MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM STANDARD RT MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Fitting Problem (2183); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

It is reported that the patient underwent a tmj procedure.Subsequently, the patient has undergone a right side revision on an unknown date due to unknown reasons.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

It is further reported that the event was an initial procedure with the surgeon choosing a different implant for fit during the initial tmj procedure.

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.No problem was identified with the product.It was identified that the mandible was just exchanged during the initial procedure due to fit choices of the surgeon.There were no allegations against the implant.The reported event is not confirmed.Upon reassessment of the reported event based on additional information, this product did not cause or contribute to the reported event.This initial report submitted needs to be voided.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.

• Brand Name: TMJ SYSTEM STANDARD RT MANDIBULAR COMPONENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16938496
• MDR Text Key: 315288609
• Report Number: 0001032347-2023-00182
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036060398
• UDI-Public: (01)00841036060398(17)170622(10)107800C
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• 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: 24-6555
• Device Lot Number: 107800C
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention