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

Model Number	N/A
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional 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; 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: 0001032347-2019-00542.Explantation date is planned for (b)(6) 2020.Medical product: tmj system right fossa component, small, part# 24-6562, lot# 630060b, tmj system right standard mandibular component, part# 24-6550, lot# 845440a, unknown screws, part# unk, lot# unk.The user facility is foreign; therefore a facility medwatch report will not be available.Report source: (b)(6).
Event or Problem Description
It was reported a revision is planned due to malocclusion.The explanted devices will be replaced by a custom implant.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint is considered confirmed as a revision surgery was reported.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 (tipqa) was reviewed for the mandible component; 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 (b)(4) , which is no greater than the occurrence listed in the afmea.The most likely underlying cause of the complaint is improper placement of the implant(s), though it was not clear from the information received if it was the position of the fossa, mandible, or both implants that led to the malocclusion.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, h6 method code, h6 results code, h6 conclusions code, and h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TMJ SYSTEM RIGHT STANDARD MANDIBULAR COMPONENT
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9428388
• Report Number: 0001032347-2019-00543
• Device Sequence Number: 19260306
• Product Code: LZD
• UDI-Device Identifier: 00841036060343
• UDI-Public: 00841036060343
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2020

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: 09/20/2023
• Device Model Number: N/A
• Device Catalogue Number: 24-6550
• Device Lot Number: 845440A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/11/2019
• Supplement Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 05/06/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention