MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT 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	Nerve Damage (1979); Numbness (2415)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).The product will not be returned to zimmer biomet for investigation because it remains implanted.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: 0001032347-2019-00379, 0001032347-2019-00380, 0001032347-2019-00381, 0001032347-2019-00382, 0001032347-2019-00383, 0001032347-2019-00384.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 the patient experienced nerve damage and numbness after implantation of temporomandibular joint implants.The patient described numbness on the right bottom of their jaw and loss of facial expression.The patient said they are only recently able to close their eyes.The patient currently receives botox injections into their forehead to help treat the issues associated with the nerve damage.The patient reported their surgeon stated that the condition is likely permanent.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 the patient reports numbness and nerve damage resulting from tmj implants.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 complaint is non-verifiable.The dhr for the right mandible component was reviewed, one non-conformance was found.Nc8172 was opened to address a minor inconsistency of a seal, however, testing proved the seal was sufficient and the part was acceptable.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding nerve damage, there is a complaint rate of 0.29%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause cannot be determined.There are no indications of manufacturing defects.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 NARROW MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8867870
• Report Number: 0001032347-2019-00378
• Device Sequence Number: 16628746
• Product Code: LZD
• UDI-Device Identifier: 00841036011857
• UDI-Public: 00841036011857
• 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): 10/31/2019

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: 01-6545
• Device Lot Number: 710730A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/01/2019
• Supplement Date Received by Manufacturer: 10/23/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 10/31/2019
• 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: Required Intervention; Disability