MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Patient Device Interaction Problem (4001); Migration (4003)

Patient Problems Headache (1880); Failure of Implant (1924); Paralysis (1997); Eye Pain (4467); Implant Pain (4561)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).Patient.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 after a temporomandibular joint revision procedure, the patient is experiencing pain, headaches, eye pain, and malposition of the joint by 4mm.

Event Description

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

Event Description

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

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 record(s) identified no deviations or anomalies during manufacturing.Medical records/ct scans were provided and reviewed by a health care professional.Review of the available records identified the following: the patient noted headaches began and worsened over time, and a ct scan was ordered to evaluate for possible infection.A facial ct scan found the implant to be 4mm out of expected place; no definite loosening was identified; no evidence of bony erosions; sinus' appear well aerated, ostiomeatal units patent bilaterally.A phone call with the patient determined the current physician is in the process of fitting new dentures to alleviate symptoms and adjust for implant migration; patient also notes left sided facial droop since revision and they eye was scratched during revision procedure.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.This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h3, h6 and h10.

Manufacturer Narrative

This report is being submitted to correct b5 and update additional information in section a1, a3, b4, b7, e1, e2, e3, g3, g6, h2, h6 and h10.

Event Description

Patient has since claimed that her left prosthesis is 4 mm laterally out of it's socket.Patient also suffers from continued headaches, noise sensitivity, facial drooping and claims the revision surgeon scratched her eye.Surgeon's plan for intervention is to provide patient with custom dentures that will correct the positioning of the prosthesis.

• Brand Name: TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL
• 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: 15234423
• MDR Text Key: 297988859
• Report Number: 0001032347-2022-00265
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: (01)00841036036584(17)210322(10)670560
• 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: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2021
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 670560B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2016
• Is the Device Single Use?: Yes
• 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): Required Intervention; Other
• Patient Sex: Female