MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 55MM / 12 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Neurological Deficit/Dysfunction (1982); Pain (1994)
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.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, 0001032347-2020-00136, 0001032347-2020-00137, 0001032347-2020-00138, 0001032347-2020-00139, 0001032347-2020-00140.Explantation date is planned for (b)(4) 2020.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 or Problem 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.
Event or Problem 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D7- the planned explantation date was (b)(6) 2020.
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.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 mandible component was reviewed.Nc8798 was opened to address the fact that the inspector used the incorrect inspection method for all four item# 24-6555, lot# 774110b; however, the parts were reinspected and determined to be acceptable.There are no indications of manufacturing defects.This is the only complaint for this part# 24-6555, lot# 774110b.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding malpositioning, there is a complaint rate of 0.19%, which is no greater than the occurrence listed in the application fmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding malocclusion, there is a complaint rate of 0.38%, which is no greater than the occurrence listed in the application fmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, there is a complaint rate of 0.34%, 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.

• Brand Name: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT 55MM / 12 HOLE
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9776497
• Report Number: 0001032347-2020-00135
• Device Sequence Number: 14007213
• Product Code: LZD
• UDI-Device Identifier: 00841036060398
• UDI-Public: 00841036060398
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2022
• Device Model Number: N/A
• Device Catalogue Number: 24-6555
• Device Lot Number: 774110B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 03/13/2020; 08/27/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/25/2020; 08/28/2020
• 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