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	Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)
Health Effect - Clinical Codes	Hearing Loss (1882); Pain (1994); Rupture (2208); Discomfort (2330)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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: 0001032347-2020-00543, 0001032347-2020-00544, 0001032347-2020-00545, 0001032347-2020-00546, 0001032347-2020-00547, 0001032347-2020-00548, 0001032347-2020-00549.Concomitant medical products: tmj system right standard mandibular component 55mm / 12 hole, part# 24-6555, lot# 873530b; tmj system left standard mandibular component 55mm / 12 hole, part# 24-6556, lot# 836280b; tmj system right fossa component, medium, part# 24-6560, lot# 861240b; tmj system left fossa component, medium, part# 24-6561, lot# 838220a; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# ni; 2.4mm system high torque (ht) cross-drive screw 2.7mm x 10mm, part# 91-2710, lot# ni; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system cross drive emergency fossa screw 2.3mm x 9mm, part# 99-6589, lot# ni.Initial reporter occupation ¿ patient.
Event or Problem Description
It was reported that the patient has experienced multiple issues following implantation of bilateral temporomandibular joint prostheses one (1) year ago.One (1) month following implantation, the patient reports their ear drum ruptured and the implants on the left side are pushing into the eustachian tube and auditory canal.The patient has lost most of their hearing on the left side and says it is too painful to wear a hearing aid.The patient reports pressure on the left cheek and sinus.The implant on the right side squeaks.The patient reports that multiple ct scans have been taken, and they are seeing an ent/oral maxillofacial specialist and neurologist.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing of the mandible and fossa components.A definitive root cause cannot 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.This report is being submitted to update additional information in section d4, h2, h3, h6 and h10.
Event or Problem Description
No further event information available at the time of this report.

• 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: 10777320
• Report Number: 0001032347-2020-00542
• Device Sequence Number: 16942795
• Product Code: LZD
• UDI-Device Identifier: 00841036060398
• UDI-Public: 00841036060398
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2021

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: 01/23/2024
• Device Model Number: N/A
• Device Catalogue Number: 24-6555
• Device Lot Number: 873530B
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 05/20/2021
• Initial Report FDA Received Date: 11/03/2020
• Supplement Report FDA Received Date: 05/25/2021
• 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: Required Intervention