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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).It is unknown at this time if the device will be returned for evaluation.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00112.Medical products: tmj system right standard titanium mandibular component, part# 24-6545ti, lot# 703580a.Tmj system right fossa component, small, part# 24-6562, lot# 721330b.Unknown screws, part# unk, lot# unk.
Event or Problem Description
It was reported the patient underwent a revision of temporomandibular joint implants on the right side.The temporomandibular joint implants were removed and replaced with stock tmj prostheses.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is confirmed as a revision surgery was reported.No product was returned as they were discarded; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The non-conformance database was reviewed for the mandible component; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint regarding heterotopic bone growth and dislocation for this part# 24-6545ti, lot# 703580a.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding heterotopic bone growth, (b)(4).For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding dislocation, (b)(4).The most likely underlying cause of the complaint is a patient condition causing heterotopic bone growth.The cause of the dislocation could not be determined from the information provided, but it is possible that it is related to the bone growth.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 or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM RIGHT STANDARD TITANIUM MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9711834
• Report Number: 0001032347-2020-00111
• Device Sequence Number: 3319723
• Product Code: LZD
• UDI-Device Identifier: 00841036075118
• UDI-Public: 00841036075118
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 08/23/2021
• Device Model Number: N/A
• Device Catalogue Number: 24-6545TI
• Device Lot Number: 703580A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 07/27/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 07/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 35 YR