MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT NARROW TITANIUM MANDIBULAR COMPONENT 45MM / 6 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00202, 0001032347-2020-00203, 0001032347-2020-00204.Medical products: tmj system left narrow titanium mandibular component 45mm / 6 hole, part# 01-6546ti, lot# 907200.Tmj system left fossa component, small, part# 24-6563, lot# 933860c.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# unk.2.4mm system 2.7mm x 10mm ht cross-drive screw,5/pk, part# 85-2710, lot# unk.The user facility is foreign; therefore, a facility medwatch report will not be available.Foreign report source: (b)(6).
Event or Problem Description
It was reported the patient will undergo a revision of temporomandibular joint implants on the left side due to trauma following a falling accident.A ct scan revealed the mandible bone fractured around the implant and the implant is displaced.The devices will be explanted and replaced with a custom implant.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered to be confirmed because a plan for a revision surgery was reported and a replacement custom tmj device was ordered.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The dhr for the mandible component was reviewed; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this item# 01-6546ti, lot# 907200.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding revision due to trauma, there is a complaint rate of 0.07%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is the patient's reported accident.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 LEFT NARROW TITANIUM MANDIBULAR COMPONENT 45MM / 6 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9940058
• Report Number: 0001032347-2020-00201
• Device Sequence Number: 19528773
• Product Code: LZD
• UDI-Device Identifier: 00841036081782
• UDI-Public: 00841036081782
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2024
• Device Model Number: N/A
• Device Catalogue Number: 01-6546TI
• Device Lot Number: 907200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/27/2020
• Supplement Date Received by Manufacturer: 09/28/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 09/28/2020
• 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