MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SM LFT FOSSA COMP; TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS

Catalog Number 24-6563

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Foreign Body In Patient (2687); Swelling/ Edema (4577)

Event Date 07/19/2023

Event Type  Injury  

Manufacturer Narrative

(b)(4).D10: 50mm lft standard mand cat# 24-6551, lot# 717020c.Unk screw cat#ni lot#ni.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 - 2023 - 00333.0001032347 - 2023 - 00335.

Event Description

It was reported that a patient is experiencing pain, swelling, and difficulty opening their mouths (rom) post implantation of a tmj prosthesis.A screw fractured and only part of it was removed.The rest was retained by the patient.Attempts have been made and additional information on the reported event is unavailable at this time.

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.Medical records were not provided.Review of the mandible and fossa 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 Description

No further event information available at the time of this report.

• Brand Name: TMJ SM LFT FOSSA COMP
• Type of Device: 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 rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 17559799
• MDR Text Key: 321287945
• Report Number: 0001032347-2023-00334
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036036584
• UDI-Public: (01)00841036036584(17)230614(10)834850
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2023
• Device Catalogue Number: 24-6563
• Device Lot Number: 834850B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other
• Patient Sex: Female