MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE GEORGE LEFT PM-TMJ & MODEL

Model Number N/A

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

Patient Problems Airway Obstruction (1699); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint: (b)(4).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.However, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: unknown screws, part# unk, lot# unk.

Event Description

It was reported the patient will undergo a revision to replace the fossa component of their custom temporomandibular joint prostheses.The fossa component will be replaced with a newly designed custom fossa component.Attempts have been made and no further information has been provided.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D7 explantation date is planned for (b)(6) 2020.

Event Description

This follow-up report is being submitted to relay additional information.It was reported the revision is due to progressive left mandibular sagging posteriorly that causes the patient's bite to shift and obstruct the airway at night.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed as a revision surgery is planned.The george left pm-tmj & model (part# tmjpm-2316, lot# 894140a) was not returned for investigation; therefore, no functional tests or inspections could be performed.The final design images were used to confirm the appropriate positioning of the devices and therefore the left mandibular sagging posteriorly and malocclusion were caused by a patient condition rather than an implant malfunction or failure.Patients with bigger resections and multiple surgeries may need a longer time for soft tissue recovery, which may explain the situation this patient is experiencing.The dhr for this product was reviewed; no non-conformances were found.There are no indications of manufacturing defects.For all patient matched tmj products (tmjpm-xxxx) in the previous one year (from the notification date) regarding malocclusion, (b)(4).The most likely underlying cause of the complaint is a patient soft tissue condition which provides insufficient stability to maintain the implants in their intended position, allowing the mandible to migrate, changing the alignment and function of the implant.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: CUSTOM MADE DEVICE GEORGE LEFT PM-TMJ & MODEL
• Type of Device: CUSTOM MADE DEVICE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9734322
• MDR Text Key: 189482235
• Report Number: 0001032347-2020-00124
• 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: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-2316
• Device Lot Number: 894140A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/27/2020
• Initial Date FDA Received: 02/20/2020
• Supplement Dates Manufacturer Received: 02/21/2020; 07/27/2020
• Supplement Dates FDA Received: 03/17/2020; 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention