MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT, 50 MM; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Difficulty Chewing (2670); Difficulty Chewing (4522)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: biomet microfixation tmj system right standard mandibular component 50 mm, catalog #: 24-6550, lot #: 530070a.Biomet microfixation tmj system left fossa component, medium, catalog #: 24-6561, lot #: 547160b.Biomet microfixation tmj system right fossa component, medium, catalog #: 24-6560, lot #: 516330b.Biomet microfixation 2.4 mm system high torque (ht) cross-drive screw 2.7 x 8 mm, catalog #: 91-2708, lot #: ni.Biomet microfixation 2.4 mm system high torque (ht) cross-drive screw 2.7 x 10 mm, catalog #: 91-2710, lot #: ni.Biomet microfixation tmj system cross drive fossa screw 2.0 x 7 mm, catalog #: 99-6577, lot #: ni.Biomet microfixation tmj system cross drive emergency fossa screw 2.3 x 9 mm, catalog #: 99-6589, lot #: ni.Biomet microfixation 2.7 mm system emergency cross drive screw 3.2 x 10 mm, catalog #: 99-9950, lot #: ni.Therapy date: unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation; it remains implanted in the patient.Reported event was unable to be confirmed due to limited information received from the customer.The product identity was confirmed through tmj tracking.No product was returned and no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.For aforementioned reasons, and due to the fact that pain is a relative condition, the complaint cannot be verified and the root cause was unable to be determined.The instructions for use for this product warns of the potential for complications.It states in the section titled adverse events: facial swelling and/or pain, facial nerve dysfunction.It also states in the section titled patient counseling information: discussion of the following points is recommended prior to surgery.The risks associated with a total tmj system (see warnings and adverse events).Post-operative pain relief and return of function varies from patient to patient.Device history record (dhr) was reviewed and no discrepancies were found.There are no indications of manufacturing defects.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.Multiple mdr reports were filed for this event; please see associated reports: 0001032347-2018-00811 through 0001032347-2018-00819.
Event or Problem Description
It was reported the patient was prescribed flexeril for thirty days for her pain in her left joint.It was stated the patient used ice packs on it every night and morning and only ate soft foods because she had difficulty eating.No additional patient consequences were 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.Lot identification is necessary for review of device history records, lot identification was not provided for the screws.A definitive root cause cannot be determined for the left side implants.No problem was found with the right side implants.Pain was reported to be experienced on the left side, so this issue is related to the left side implants and no allegations were made against the right side implants.The reported event is unconfirmed.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 sections b4, b5, d4, g3, g6, h2, h3, h6 and h11.
Event or Problem Description
It was reported that the patient is alleging that they are still experiencing unknown issues; however, no intervention has been reported to date.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT, 50 MM
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 8116748
• Report Number: 0001032347-2018-00813
• Device Sequence Number: 252146
• Product Code: LZD
• UDI-Device Identifier: 00841036060329
• UDI-Public: (01)00841036060329(10)541960(17)190601(30)1
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 10/25/2024

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: 06/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6551
• Device Lot Number: 541960A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2018
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female