MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD 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)
Type of Reportable Event	Serious Injury
Additional 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; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00068, 0001032347-2020-00070, 0001032347-2020-00071, 0001032347-2020-00072, 0001032347-2020-00073, 0001032347-2020-00074.Medical products: tmj system right standard mandibular component, part# 24-6555, lot# 842720b, tmj system left standard mandibular component, part# 24-6556, lot# 793820b, tmj system right fossa component, small, part# 24-6562, lot# 861210a, tmj system left fossa component, small, part# 24-6563, lot# 864820a, 2.4mm system high torque (ht) cross-drive screw, part# 91-2710, lot# unk, tmj system cross drive fossa screw, part# 99-6577, lot# unk, tmj system cross drive fossa screw, part# 99-6579, lot# unk.
Event or Problem Description
It was reported the patient underwent a bilateral revision of temporomandibular joint prostheses due to an unknown reason.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As a revision surgery was reported, the complaint is confirmed.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.Three follow-up attempts were made to gather additional information including the failure mode that led to the need for a revision surgery; however, no additional information was gathered.The dhr for the mandible component was reviewed.Nc8977 was opened to address one 24-6556 that was scrapped for being undersized.There are no indications of manufacturing defects.This is the only complaint involving part# 24-6556, lot# 793820b.The most likely underlying cause of the complaint 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.
Additional Manufacturer Narrative
The following fields were updated: b4 date of this report.B5 describe event or problem.G7 type of report.H2 follow up type.H10 additional narratives/data.
Event or Problem Description
New information was received that no revision occurred.Therefore, this is not a reportable event.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9592359
• Report Number: 0001032347-2020-00069
• Device Sequence Number: 459164
• Product Code: LZD
• UDI-Device Identifier: 00841036036508
• UDI-Public: 00841036036508
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/15/2020

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: 02/23/2023
• Device Model Number: N/A
• Device Catalogue Number: 24-6556
• Device Lot Number: 793820B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 06/25/2020; 06/25/2020
• Initial Report FDA Received Date: 01/15/2020
• Supplement Report FDA Received Date: 06/29/2020; 07/15/2020
• 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