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

Model Number	N/A
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).It is unknown at this time if the device will be returned for evaluation.The product remains implanted in the patient, but a revision is planned at a later date at which time the device may be returned for testing.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2019-00427, 0001032347-2019-00428, 0001032347-2019-00429.Explantation date is planned for (b)(6) 2020.Concomitant medical products: tmj system left standard mandibular component, cat# 24-6546, lot#416150; tmj system right standard mandibular component, cat# 24-6550, lot# 295391; tmj system right fossa component, cat# 24-6560, lot# 360330.Report source: - patient.
Event or Problem Description
It was reported that the patient's right temporomandibular implant failed and became unattached at the bone.A revision is planned to remove the patient's bilateral tmj implants and replace with a custom device.No additional patient consequences were reported.
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.Explanation date was reported to be sometime in (b)(6) 2020.
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.The complaint was opened because tmj tracking coordinator reports that a revision will occur.No product was returned; therefore, no functional tests or inspections could be performed.No x-rays, scans, pictures, or physician's reports were provided.Because it was reported that a revision surgery was scheduled, the complaint is confirmed.It was reported that "the right implant failed and became unattached at the bone.The patient is opting to replace both implants at the same time because the implants do not last forever." the revision surgery date is scheduled for february 24, 2020 and the explanted devices will be replaced with custom implants.For all non-custom tmj fossa implants in the previous one year (from the notification date) involving implants detaching, there is a complaint rate of 0.141%, which is no greater than the occurrence listed in the afmea.The non-conformance database (tipqa) was reviewed for these products, no non-conformances were found.There are no indications of manufacturing defects.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, g4 date received by manufacturer, g7 type of report, h2 follow up type, h3 device evaluated by manufacturer, h6 method code, h6 results code, h6 conclusions code, h10 additional narratives/data.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; e1; e2; e3; g2; g3; g6; h1; h2; h6 this file was reopened because new information was received that indicated the planned revision has occurred.The root cause of the previous investigation does not change as a result of this new information.If any further information 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 or Problem Description
No further event information available at the time of this report.

• Brand Name: TMJ SYSTEM LEFT FOSSA COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9158471
• Report Number: 0001032347-2019-00430
• Device Sequence Number: 2802443
• Product Code: LZD
• UDI-Device Identifier: 00841036036546
• UDI-Public: 00841036036546
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2004
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/21/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/25/2008
• Device Model Number: N/A
• Device Catalogue Number: 24-6561
• Device Lot Number: 360310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 12/18/2019; 09/22/2020; 09/20/2021
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 01/17/2020; 10/07/2020; 09/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention