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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Necrosis (1971); Nerve Damage (1979); Numbness (2415)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).The device will not be returned to zimmer biomet for investigation because it remains implanted.The investigation is in process.Once the investigation is completed, a follow-up mdr report will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00371, 0001032347-2019-00373, 0001032347-2019-00374; 0001032347-2019-00375, 0001032347-2019-00376, 0001032347-2019-00377.Concomitant medical products: tmj system right narrow mandibular component, cat# 01-6545, lot# 710730a; tmj system left narrow mandibular component, cat# 01-6546, lot# 541380d; tmj system right fossa component small, cat# 24-6562, lot# 721350a; tmj system left fossa component small, cat# 24-6563, lot# 721500a; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2708, lot# unk; "2.4mm" system high torque (ht) cross-drive screw, cat# 91-2710, lot# unk; tmj system cross drive fossa screw, cat# 99-6579, lot# unk.
Event or Problem Description
It was reported that the patient underwent surgery to reposition temporomandibular implants due to necrosis and being too close to the ear canal.Implants remain implanted.The patient experienced numbness on the right bottom of their jaw and loss of facial expression that has not resolved following the repositioning of the implants.No additional patient consequences were reported.
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 was opened because taylor billard, tmj tracking coordinator reports revision due to necrosis.Because a revision surgery occurred, the complaint is confirmed.No product was returned, therefore no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.It was reported that "the surgeon had to redo her right side due to necrosis and that it was the surgeon's fault and not our fault." there was no alleged malfunction of the devices.The non-conformance database was reviewed for the mandible and fossa components.Nc8172 was opened to evaluate the seals created by the atlas vac sealer, however, it was determined that the seals were of adequate strength and integrity.There are no indications of manufacturing defects.This was the only complaint for these lots for the mandible and fossa components.The most likely underlying cause could not be determined from the information provided.It is possible that there was a patient condition that led to the issue.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 LEFT NARROW MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8867844
• Report Number: 0001032347-2019-00372
• Device Sequence Number: 10893939
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: 00841036011871
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2019

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 Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 541380D
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 10/07/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/30/2019
• 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