MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT, 45 MM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abdominal Pain (1685)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint: (b)(4).Concomitant medical product ¿ zimmer biomet 2.3x7mm fossa cross-drive screw, catalog #: 99-6587, lot #: ni; zimmer biomet tmj system left fossa component, small, catalog #: 24-6563, lot #: 826700, zimmer biomet tmj system cross drive fossa screw, 2.0 x 7mm, catalog #: 99-6577, lot #: ni; zimmer biomet tmj system high torque cross-drive screw, catalog #: 91-2710, lot #: ni.Occupation ¿ patient.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: 0001032347-2019-00346, 0001032347-2019-00347, 0001032347-2019-00348, 0001032347-2019-00350.
Event or Problem Description
It was reported that since the time the product was implanted in (b)(6) 2009, the patient has experienced pain and has had "everything from injections to stunning the trigeminal nerve to now having a pns device to try and get pain levels under control".No additional patient consequences were reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint cannot be verified.Based on the information and materials available, there has not been any revision or plan for one reported.Functional testing and inspections could not be performed due to the parts not being returned and no photographs, x-rays, ct scans, or physician reports being provided.The non-conformance database (tipqa) was reviewed for the known part and lot combinations and there were no non-conformances found.For all non-custom tmj mandible implants in the previous year (from the notification date), there is a complaint rate of 2.13% for the implant causing pain, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Event or Problem Description
This follow-up report is being submitted to relay additional information.The patient reports she is on many oral pain medications and anti-inflammatories, and has tried medical marijuana for pain relief.The patient reports that she has been advised by an oral surgeon not to have any more work performed on her jaw.

• Brand Name: TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT, 45 MM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 8762949
• Report Number: 0001032347-2019-00349
• Device Sequence Number: 2637536
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: 00841036011871
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2020

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: 04/01/2011
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 694740
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 09/11/2019; 06/12/2020
• Initial Report FDA Received Date: 07/04/2019
• Supplement Report FDA Received Date: 09/11/2019; 06/18/2020
• 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: Required Intervention