MAUDE Adverse Event Report: BIOMET MICROFIXATION 50MM LFT NARROW MAND; TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS

Catalog Number	01-6551
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Concomitant medical products: tmj sm lft fossa comp, cat# 24-6563, lot# 772490a.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 - 2021 - 00538.
Event or Problem Description
It was reported that a patient underwent a tmj revision procedure.Subsequently, the patient is experiencing constant pain 24 hours a day.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
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 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.
Event or Problem Description
No further event informatiion is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h6 and h10.
Event or Problem Description
It is further reported that the patient is still experiencing pain even after having five procedures.

• Brand Name: 50MM LFT NARROW MAND
• 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: 12893927
• Report Number: 0001032347-2021-00537
• Device Sequence Number: 18741370
• Product Code: LZD
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/09/2022

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: 12/01/2018
• Device Catalogue Number: 01-6551
• Device Lot Number: 510880A
• 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: 11/15/2021
• Supplement Date Received by Manufacturer: 02/22/2022; 10/23/2022; 11/28/2022
• Initial Report FDA Received Date: 11/30/2021
• Supplement Report FDA Received Date: 03/03/2022; 11/22/2022; 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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 H10.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female