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

Model Number N/A

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

(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.The product remains implanted in the patient, but a revision is planned at a later unspecified date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00134, 0001032347-2020-00135, 0001032347-2020-00136, 0001032347-2020-00138, 0001032347-2020-00139, 0001032347-2020-00140.Explantation date is planned for (b)(6) 2020.Concomitant medical products: tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 775470b; tmj system right standard mandibular component 55mm / 12 hole, part# 24-6555, lot# 774110b; tmj system right fossa component, small, part# 24-6562, lot# 783360a; tmj system left fossa component, small, part# 24-6563, lot# 787860c; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# unk; 2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# unk; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# unk.

Event Description

It was reported that patient will undergo a revision of bilateral temporomandibular joint implants due to the development of cervical dystonia.A revision is planned but has not yet occurred.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D7- the planned explantation date was (b)(6) 2020.

Event Description

This follow-up report is being submitted to relay additional information.It was reported the patient will undergo removal of bilateral temporomandibular joint implants due to pain, malocclusion, and malpositioning with erosion of the exterior auditory canal.The surgeon does not believe the devices are defective.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is considered confirmed because a revision surgery date was confirmed with the surgeon.No product was returned; therefore, no functional tests or inspections could be performed.The dhr for the fossa component was reviewed and no non-conformances were found.There are no indications of manufacturing defects.This is the only complaint for this part# 24-6563, lot# 787860c.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding malpositioning, there is a complaint rate of 0.26%, which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding malocclusion, there is a complaint rate of 0.48%, which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, there is a complaint rate of 0.48%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint is due to the malpositioning of the devices.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: 9776519
• MDR Text Key: 195475672
• Report Number: 0001032347-2020-00137
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2022
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 787860C
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/02/2020
• Supplement Dates Manufacturer Received: 03/13/2020; 08/28/2020
• Supplement Dates FDA Received: 03/25/2020; 08/28/2020
• 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