MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM RIGHT NARROW MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number	N/A
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Pain (1994); Scarring (2061); Fibrosis (3167); No Code Available (3191)
Date of Event	10/11/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision may occur at a later unspecified date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00482.Concomitant medical products: tmj system right narrow mandibular component, part# 01-6550, lot# unknown.Tmj system right fossa component, small, part# 01-6562, lot# unknown.Unknown screws, part# unknown, lot# unknown.
Event or Problem Description
It was reported a patient had a revision scheduled to remove temporomandibular joint prostheses on the right side due to an unknown reason.Attempts were made to gather additional information but none was provided.No additional patient consequences were reported.
Event or Problem Description
This follow-up report is being submitted to relay additional information.It was reported the revision occurred due to device migration which caused pain and malocclusion.The surgeon noted the presence of benign fibrocartilage with scarring in the right tmj.The explanted devices were replaced with new tmj devices.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.As a revision surgery was confirmed by the surgeon, the complaint is confirmed.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, or pictures were provided.Evaluation was provided from the clinical research team: interpositional fibrotic tissue growth caused an anterior dislocation of the implant, explaining the malocclusion and ultimately leading to failure (removal).Pain is also present.However, keep in mind that pain is a feature of the baseline disease for which this patient received a total joint replacement, and there is a high probability that pain was in place before the implantation of the biomet device.The non-conformance database (tipqa) was reviewed, no non-conformances were found.There are no indications of manufacturing defects.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding malocclusion, there is a complaint rate of 0.297%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding pain leading to a revision surgery, there is a complaint rate of 0.41%, which is no greater than the occurrence listed in the afmea.For all non-custom tmj mandibular implants in the previous one year (from the notification date) regarding dislocation, there is a complaint rate of 0.186%, which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the complaint is the patient's condition.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.D10 device availability.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 RIGHT NARROW MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9295759
• Report Number: 0001032347-2019-00481
• Device Sequence Number: 16245722
• Product Code: LZD
• UDI-Device Identifier: 00841036011895
• UDI-Public: 00841036011895
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2001
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/26/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2003
• Device Model Number: N/A
• Device Catalogue Number: 01-6550
• Device Lot Number: 261360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 11/12/2019; 03/17/2020
• Initial Report FDA Received Date: 11/08/2019
• Supplement Report FDA Received Date: 12/05/2019; 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention