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

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problems Pain (1994); Pocket Erosion (2013); No Information (3190)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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: 0001032347-2020-00046.Medical products: tmj system left fossa component, small, part# 24-6563, lot# 166520a, tmj system left standard offset mandibular component, part# 24-6551, lot# 770680, unknown screws, part# unk, lot# unk.Occupation: patient.

Event Description

It was reported the patient is having issues with their temporomandibular joint implants on the left side and may undergo a revision at an unspecified date.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and information.The following fields were updated: b4 date of this report b5 describe event or problem g4 date received by manufacturer g7 type of report h2 follow up type h6 patient code h6 device code h10 additional narratives/data.

Event Description

It was reported the patient has been experiencing constant noise and occasional pain nine years post-operatively following implantation of temporomandibular joint prostheses on the left side.The patient reports that she has received two fat grafts and been prescribed multiple steroids to address her issues and adequate relief has not been achieved.No additional patient consequences were reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is non-verifiable.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 non-conformance database was reviewed for the fossa component, and no non-conformances were found.There are no indications of manufacturing defects.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding noise, there is a complaint rate of 1.33%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain, there is a complaint rate of 2.45%, which is no greater than the occurrence listed in the afmea.This is the only complaint regarding noises or pain for this part# 24-6563, lot# 166520a.The most likely underlying cause of the complaint cannot 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.

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.This report is being submitted to update additional information in section b5, h2, h6 and h10.

Event Description

It was reported the patient has been experiencing constant noise and occasional pain nine years post-operatively following implantation of temporomandibular joint prostheses on the left side.The patient reports that she has received two fat grafts and been prescribed multiple steroids to address her issues and adequate relief has not been achieved.The patient reports pockets on her left gums that will be treated by a periodontist.The patient is following up with a maxillofacial surgeon in two (2) months to discuss her concerns.It was reported that no further information is available.

Event Description

It is further reported that the patient alleges they are continuing to experience ongoing pain and noises in their left side implants.The patient also alleges that they will undergo a future revision procedure.However, no revision procedure has been reported to date.

Manufacturer Narrative

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

Event Description

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

• Brand Name: TMJ SYSTEM LEFT FOSSA COMPONENT, SMALL
• 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: 9575695
• MDR Text Key: 174600749
• Report Number: 0001032347-2020-00045
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: 00841036036584
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 166520A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10 NARRATIVE
• Patient Outcome(s): Required Intervention