MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT 45 MM / 6 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); Pain (1994); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet (b)(4).The device will not be returned for analysis as it remains implanted; 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: 0001032347-2020-00352, 0001032347-2020-00353, 0001032347-2020-00354, 0001032347-2020-00355.Medical products: 2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni; tmj system cross drive emergency fossa screw 2.3mm x 7mm, part# 99-6587, lot# ni; tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni; tmj system left narrow mandibular component 45 mm / 6 hole, part# 01-6546, lot# 694740; tmj system left fossa component, small, part# 24-6563, lot# 826700.Occupation ¿ patient.

Event Description

It was reported by the patient that they are experiencing various issues following implantation of temporomandibular joint implants on the left side approximately eleven (11) years ago.The implanting surgeon reports that there were no issues with the implants during follow-up appointments.The patient reports a gash on the inside of the right cheek.The patient has received nerve blocks that are inadequate in providing pain relief.The patient reports seeing a neurosurgeon for a neurostimulator implant to treat pain.No additional patient consequences have been reported.

Event Description

This follow-up report is being submitted to relay additional information.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed because additional measures were reported to have been taken to help the patient manage her pain.No product was returned as the devices remain implanted; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.The non-conformance database was reviewed for the mandible component; no non-conformances were found.There are no indications of manufacturing defects.There have been 4 complaints of pain for this item# 01-6546, lot# 694740, all from this same patient.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding pain, there is a complaint rate of 2.47%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause could not 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.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

No further event information available at the time of this report.

Event Description

It is further reported that the patient is still in pain and now has an implanted neuro stimulator with the leads going to the trigeminal nerve and to the back of her head to alleviate severe headaches.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, g3, e1, e2, e3, g2, g6, h2, h6, h10.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned as the devices remain implanted, therefore no functional tests or inspections could be performed.No medical records were provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.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.

Event Description

No further event information available at the time of this report.

• Brand Name: TMJ SYSTEM LEFT NARROW MANDIBULAR COMPONENT 45 MM / 6 HOLE
• Type of Device: 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: jennifer delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 10367774
• MDR Text Key: 201725100
• Report Number: 0001032347-2020-00355
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: 00841036011871
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2013
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 694740
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention