MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

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

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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: 0001032347-2020-00207, 0001032347-2020-00208, 0001032347-2020-00209, 0001032347-2020-00210, 0001032347-2020-00211, 0001032347-2020-00212.Concomitant medical products: tmj system right standard mandibular component 45mm / 7 hole, part# 24-6545, lot# 535280a.Tmj system left standard mandibular component 45mm / 7 hole, part# 24-6546, lot# 567720a.Tmj system right fossa component, small, part# 24-6562, lot# 503450a.Tmj system left fossa component, small, part# 24-6563, lot# 501530a.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# ni.Tmj system cross drive fossa screw 2.0mm x 7mm, part# 99-6577, lot# ni.Initial reporter ¿ patient.

Event Description

It was reported by the patient that a revision may occur following implantation of bilateral temporomandibular joint implants five (5) years ago due to pain and limited range of motion.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 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 these parts.Nc6232 was opened to address 1 item# 24-6546 of the lot of 4 that did not fit the overlay.The part was scrapped.There are no indications of manufacturing defects with the parts involved in this case.There have been 3 complaints for this item# 24-6546, lot# 567720a.The other 2 are the previous reports from this patient.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding pain leading to a revision, there is a complaint rate of 0.33%, which is no greater than the occurrence listed in the application fmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding limited range of motion leading to a revision, there is a complaint rate of 0.15%, which is no greater than the occurrence listed in the application fmea.The most likely underlying cause of the complaint 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.The following fields were updated: b4 date of this report b5 describe event or problem d4 expiration date g4 date received by manufacturer g7 type of report h2 follow up type h3 device evaluated by manufacturer h4 device manufacturer date h6 method code h6 results code h6 conclusions code h10 additional narratives/data.

• Brand Name: TMJ SYSTEM LEFT STANDARD MANDIBULAR COMPONENT 45MM / 7 HOLE
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9949687
• MDR Text Key: 187255232
• Report Number: 0001032347-2020-00208
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036454
• UDI-Public: 00841036036454
• Combination Product (y/n): N
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2019
• Device Model Number: N/A
• Device Catalogue Number: 24-6546
• Device Lot Number: 567720A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/25/2020
• Initial Date FDA Received: 04/10/2020
• Supplement Dates Manufacturer Received: 09/08/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention