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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet tmj system small right fossa comp catalog #: 24-6562 lot #: 085180b; zimmer biomet tmj system rigt narrow mandibular component catalog #: 01-6545 lot #: 093610a.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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2024-00016 & 0001032347-2024-00017.
Event or Problem Description
It was reported that the patient underwent tmj replacement surgery approximately one year ago.Subsequently, the patient is experiencing pain and swelling.The patient has received botox shots, gabapentin, antibiotics, physical therapy, and allergy testing which was non-reactive.It was reported that no further information is available.
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.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Medical records/radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: postsurgical changes from recent right temporomandibular joint arthroplasty redemonstration of postsurgical changes following right tmj arthroplasty with decreasing subcutaneous emphysema and fatty stranding along the right facial soft tissues.Streak artifact from the surgical hardware obscures the surgical bed and surrounding soft tissues without well-defined fluid collection or abscess within the limitations of the exam.Indication: maxillofacial pain.Post surgical changes who is status post right tmj arthroplasty.Soft tissue swelling within the right face along the right parotid gland and the subcutaneous fat overlying the region of the arthroplasty.The soft tissue swelling and stranding appears to have been previously present.Limited evaluation due to the prominent artifact from the arthroplasty hardware.No definite fluid collection seen.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 RIGT 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: 18534055
• Report Number: 0001032347-2024-00017
• Device Sequence Number: 6778862
• Product Code: LZD
• UDI-Device Identifier: 00841036011857
• UDI-Public: (01)00841036011857(17)270317(10)093610A
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2024

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 Model Number: N/A
• Device Catalogue Number: 01-6545
• Device Lot Number: 093610A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2023
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 01/18/2024
• Supplement Report FDA Received Date: 05/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2022
• 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
• 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: Required Intervention
• Patient Sex: Female