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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Pain (1994); Scarring (2061); Fibrosis (3167); No Code Available (3191)

Event Date 10/11/2019

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00481.Medical products: tmj system right narrow mandibular component, part# 01-6550, lot# unknown, tmj system right fossa component, small, part# 01-6562, lot# unknown, unknown screws, part# unknown, lot# unknown.

Event Description

It was reported a patient had a revision scheduled to remove temporomandibular joint prostheses on the right side due to an unknown reason.Attempts were made to gather additional information but none was provided.No additional patient consequences were reported.

Event Description

This follow-up report is being submitted to relay additional information.It was reported the revision occurred due to device migration which caused pain and malocclusion.The surgeon noted the presence of benign fibrocartilage with scarring in the right tmj.The explanted devices were replaced with new tmj devices.

Manufacturer Narrative

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

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.As a revision surgery was confirmed by the surgeon, the complaint is confirmed.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, or pictures were provided.Evaluation was provided from the clinical research team: interpositional fibrotic tissue growth caused an anterior dislocation of the implant, explaining the malocclusion and ultimately leading to failure (removal).Pain is also present.However, keep in mind that pain is a feature of the baseline disease for which this patient received a total joint replacement, and there is a high probability that pain was in place before the implantation of the biomet device.The non-conformance database (tipqa) was reviewed, no non-conformances were found.There are no indications of manufacturing defects.(b)(4).The most likely underlying cause of the complaint is the patient's condition.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.

• Brand Name: TMJ SYSTEM RIGHT FOSSA COMPONENT, SMALL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9295783
• MDR Text Key: 165594835
• Report Number: 0001032347-2019-00482
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2004
• Device Model Number: N/A
• Device Catalogue Number: 01-6562
• Device Lot Number: 109290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2020
• 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