MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT 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)
Date of Event	04/01/2019
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.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00034, 0001032347-2020-00035, 0001032347-2020-00036, 0001032347-2020-00037, 0001032347-2020-00038.Medical products: tmj system right standard mandibular component, part# 24-6550, lot# 575530d, tmj system right fossa component, small, part# 24-6562, lot# 718530e, 2.4mm system high torque (ht) cross-drive screw, part# 91-2712, lot# unk, tmj system cross drive fossa screw, part# 99-6577, lot# unk, tmj system cross drive fossa screw, part# 99-6579, lot# unk, tmj system cross drive fossa screw, part# 99-6581, lot# unk.
Event or Problem Description
It was reported the patient underwent a revision of temporomandibular joint implants on the right side due to an unknown reason.Stock mandible and fossa implants were removed and replaced with new stock implants.No additional patient consequences were reported.
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.A non-conformance was created as a blanket deviation for eight tmj mandibular labels that had a manufacture date of 01/01/2015, which should have been 01/13/15.There are no indications of manufacturing defects.This is the only complaint involving part# 24-6550, lot# 575530d.The most likely underlying cause of the complaint could not 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9569679
• Report Number: 0001032347-2020-00033
• Device Sequence Number: 11533057
• Product Code: LZD
• UDI-Device Identifier: 00841036060343
• UDI-Public: 00841036060343
• 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: 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): 06/25/2020

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: 01/13/2020
• Device Model Number: N/A
• Device Catalogue Number: 24-6550
• Device Lot Number: 575530D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 06/24/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 06/25/2020
• 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