MAUDE Adverse Event Report: BIOMET MICROFIXATION CUSTOM MADE DEVICE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/08/2024

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).G2: foreign - canada.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

Event Description

It was reported that the custom tmj did not fit because the teeth were not in occlusion on the model.A stock fossa and mandible were used in attempt to make it fit.However, these also did not work and surgeon had re-opened the patient and changed the other stock implants.The two final implants matched the anatomy of the patient.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.

Event Description

It was further reported that the issue was identified during the same procedure and the patient was not re-opened.There was a three-hour delay in surgery due to the need to change implants multiple times.

• Brand Name: CUSTOM MADE DEVICE
• 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: 18846117
• MDR Text Key: 336997063
• Report Number: 0001032347-2024-00087
• Device Sequence Number: 1
• Product Code: LZD
• UDI-Device Identifier: 00888233074728
• UDI-Public: (01)00888233074728(10)281020(10)66476329
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TMJPM-4267
• Device Lot Number: 664746329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2023
• 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
• Patient Outcome(s): Other