MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM MED RT FOSSA COMP; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Malposition of Device (2616); Adverse Event Without Identified Device or Use Problem (2993); Noise, Audible (3273)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).D10 ¿ medical products item # 24-6645, lot # 502220a; tmj system 45 mm right standard offset mandibular comp.G2: consumer: patient.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: 0001032347-2023-00290.

Event Description

It was reported a patient had a right side tmj procedure.Subsequently, the patient is suffering from pain.Patient also hears grinding sounds on the implanted right side.Patient is expecting to have a left initial tmj procedure in the future.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

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.A definitive root cause cannot be determined.The reported event is unconfirmed.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.

Manufacturer Narrative

This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h6, and h10.

Event Description

It is further reported that patient is alleging that they are experiencing severe middle ear pain, metal on metal sounds when chewing on the left side, and while chewing the lower jaw pulls to the right side which is the implant side.The patient has an appointment scheduled with a new surgeon; however, no revision procedure or further intervention has been reported to date.

• Brand Name: TMJ SYSTEM MED RT FOSSA COMP
• Type of Device: 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: 17436211
• MDR Text Key: 320172309
• Report Number: 0001032347-2023-00291
• Device Sequence Number: 1
• Product Code: LZD
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2017
• Device Model Number: N/A
• Device Catalogue Number: 24-6560
• Device Lot Number: 559700B
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other