MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

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: 0001032347-2020-00201, 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 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.

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 fossa component was reviewed; no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this item# 24-6563, lot# 933860c.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding revision due to trauma, there is a complaint rate of 0.10%, 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 Description

This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9940164
• MDR Text Key: 189460265
• Report Number: 0001032347-2020-00202
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: 00841036036584
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 933860C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE.
• Patient Outcome(s): Hospitalization; Required Intervention