MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM 45 MM LEFT NARROW MANDIBULAR COMPONENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Catalog Number	01-6546
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Headache (1880); Pain (1994); Loss of Range of Motion (2032); Numbness (2415); Neck Pain (2433); Ptosis (2620); Difficulty Chewing (4522); Swelling/ Edema (4577); Ear Pain (4812)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Multiple mdr reports were filed for this event.Associated reports are available for the applicable concomitant products below in the d10 narrative.D10: concomitant medical products, part (lot): 24-6563 (789950c).Associated product information: 91-2710 (unknown) qty 5, 99-6577 (unknown) qty 4, 99-6589 (unknown) qty 1.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found that would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported that a patient with a left temporomandibular joint implant placed approximately six (6) years and seven (7) months ago has experienced ongoing dental issues, range of motion limitations, and discomfort.For approximately one (1) year and three (3) months, the patient has been on a soft diet due to persistent symptoms without improvement.The patient underwent a procedure to address exposed bone in the gums at an unknown time.The patient reports severe pain associated with dentures, neck discomfort, earache-like symptoms, and headaches.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.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 or Problem Description
It was further reported that a patient underwent a revision of left tmj arthroplasty products due to a recall of competitor products approximately six (6) years and nine (9) months ago.Following the procedure, the patient experienced drooling associated with numbness and a drooping eyelid.A few years later, the patient developed increased pain, swelling, deviation in mouth opening, and fatigue with chewing prior to a teeth extraction surgery.After the extraction, the left symptoms resolved, but the patient began experiencing complications with the contralateral jaw, which does not contain implants, including jaw discomfort, neck involvement, earaches, and headaches.Radiographic imaging shows all implants remain in place with no evidence of complications.Attempts have been made, and no further information has been provided.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; b6; d2; g1; g3; g6; h1; h2; h3; h6.The reported event is confirmed, based on medical records.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified no deviations or anomalies during manufacturing.Medical records were provided and reviewed by a healthcare professional (b6).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 SYSTEM 45 MM LEFT NARROW MANDIBULAR COMPONENT
• 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: 21344531
• Report Number: 0001032347-2025-00080
• Device Sequence Number: 12683957
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: (01)00841036011871(17)211202(10)723810A
• 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: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 12/02/2021
• Device Catalogue Number: 01-6546
• Device Lot Number: 723810A
• Was Device Available for Evaluation?: No
• 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: 01/15/2025
• Supplement Date Received by Manufacturer: 02/09/2025; 03/25/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 03/05/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2016
• 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: H11.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 111 KG