MAUDE Adverse Event Report: BIOMET MICROFIXATION 45MM LFT NARROW MAND; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Type  Injury  

Event Description

It was reported that a patient underwent a tmj arthroplasty.Subsequently, the patient has a follow up with the oral surgeon because of an unknown issue with the implant.No further intervention has been reported to date.Attempts have been made and no further information has been provided.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G3: consumer: patient.D10 ¿ medical products.Rt mand item # 01-6545, lot # 563570c; 45mm rt narrow mand.Lf mand item # 01-6546, lot # 555840c; 45mm lft narrow mand.Rt fossa item # 24-6562, lot# 641670b; tmj sm rt fossa comp.Lft fossa item #24-6563, lot # 646170a; tmj sm lft fossa comp.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: 0001032347-2024-00012, 0001032347-2024-00013, 0001032347-2024-00014, 0001032347-2024-00015.

Manufacturer Narrative

Additional information received does not change the complaint investigation; a definitive root cause remains unknown.

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 that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in sections b4, b5, g3, g6, h2, h3, h6, and h10.

Event Description

It is further reported that the patient communicated that they have not seen a surgeon for a follow-up yet.Patient will contact us once they have seen a surgeon and determined what treatment is needed.

Event Description

It is further reported by the patient that both sides of her mouth are a little tight which results in not being able to open her mouth as wide.She has a dull pain all the time and it¿s hard to eat.She is waiting to see her dentist in the next few weeks to get a referral to a surgeon.

Manufacturer Narrative

This report is being submitted to update additional information in sections.

• Brand Name: 45MM LFT NARROW MAND
• 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: 18526054
• MDR Text Key: 333035767
• Report Number: 0001032347-2024-00013
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00841036011871
• UDI-Public: (01)00841036011871(17)170324(10)555840
• 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: Study,Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2017
• Device Model Number: N/A
• Device Catalogue Number: 01-6546
• Device Lot Number: 555840C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2014
• 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