MAUDE Adverse Event Report: BIOMET MICROFIXATION 45MM RT STANDARD MANDIBULAR; TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS

Catalog Number	24-6545
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Erythema (1840)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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 was reported that a patient began to experience facial sweating and erythema approximately two (2) years postimplantation of a cocr tmj mandibular component.There are currently no signs of infection and the surgeon is testing the patient for metal (nickel) sensitivity prior to considering a replacement device.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 45MM RT STANDARD MANDIBULAR
• Common Device Name: TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12737903
• Report Number: 0001032347-2021-00506
• Device Sequence Number: 4238566
• Product Code: LZD
• UDI-Device Identifier: 00841036036430
• UDI-Public: (01)00841036036430(17)230405(10)810900
• 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: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2022

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: 04/05/2023
• Device Catalogue Number: 24-6545
• Device Lot Number: 810900D
• 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: 10/13/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 11/02/2021
• Supplement Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2018
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female