MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SM LFT FOSSA COMP; JOINT, TEMPOROMANDIBULAR, IMPLANT

Catalog Number	24-6563
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Complaint: (b)(4).D10: medical products: item# 24-6556, lot 582450b; tmj system 55mm lft standard mand.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.
Event or Problem Description
It is reported that the patient underwent a bilateral temporomandibular joint procedure.Subsequently, the patient underwent a left side revision due to unknown reasons.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information and/or corrected information.Updated: d4, d5, d10, h2, h3, h4, h6 and h11.D10 - associated products - pn: 24-6555, item name: 55mm rt standard mandible, ln: 485910a.Pn: 24-6562, item name: tmj sm rt fossa, ln: 791830c.Reported event was unable to be confirmed due to limited information received from the customer and product was not returned.Dhr was reviewed and no discrepancies related to the reported event were found.A definitive root cause cannot 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.

• Brand Name: TMJ SM LFT FOSSA COMP
• Common Device Name: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21445849
• Report Number: 0001032347-2025-00095
• Device Sequence Number: 15252965
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: (01)00841036036584(17)220628(10)765100
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: Lay User/Patient
• Device Expiration Date: 06/28/2022
• Device Catalogue Number: 24-6563
• Device Lot Number: 765100A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 05/21/2025
• Initial Report FDA Received Date: 02/24/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11; SEE H11
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Unknown