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

Model Number N/A

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

Patient Problems Pain (1994); Scar Tissue (2060); Scar Excision (2358); Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (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: 0001032347-2020-00242, 0001032347-2020-00243, 0001032347-2020-00244, 0001032347-2020-00246, 0001032347-2020-00247, 0001032347-2020-00248.Medical products: tmj system right standard mandibular component 50mm / 9 hole, part# 24-6550, lot# 143380.Tmj system left standard mandibular component 50mm / 9 hole, part# 24-6551, lot# 164350.Tmj system right fossa component, small, part# 24-6562, lot# 328390.Tmj system left fossa component, small, part# 24-6563, lot# 212940.2.4mm system high torque (ht) cross-drive screw 2.7mm x 8mm, part# 91-2708, lot# unk.2.4mm system high torque (ht) cross-drive screw 2.7 x 10mm, part# 91-2710, lot# unk.Tmj system cross drive fossa screw 2.0mm x 9mm, part# 99-6579, lot# unk.Initial reporter patient.

Event Description

It was reported the patient underwent a scar tissue removal procedure and currently undergoes pain management following implantation of bilateral temporomandibular joint implants twelve years ago.The patient reported a scar tissue removal procedure two (2) years ago.The patient attends a pain management consult every six (6) to eight (8) weeks.The patient has previously received cortisone shots and is currently on botox shots, celebrex and oxycodone.No additional patient consequences have been reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed.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; no non-conformance's were found.There are no indications of manufacturing defects.There have been 5 complaints of pain and 2 complaints of scar tissue for this item# 24-6563, lot# 212940.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding pain, there is a complaint rate of (b)(4), which is no greater than the occurrence listed in the application fmea.For all non-custom tmj fossa implants in the previous one year (from the notification date) regarding scar tissue, there is a complaint rate of (b)(4), 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.

Event Description

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

• 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
• MDR Report Key: 10112129
• MDR Text Key: 194968158
• Report Number: 0001032347-2020-00245
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: 00841036036584
• 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: 11/05/2020

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: 02/01/2012
• Device Model Number: N/A
• Device Catalogue Number: 24-6563
• Device Lot Number: 212940
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/13/2020
• Initial Date FDA Received: 06/02/2020
• Supplement Dates Manufacturer Received: 11/04/2020
• Supplement Dates FDA Received: 11/05/2020
• 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): Hospitalization; Required Intervention