MAUDE Adverse Event Report: BIOMET MICROFIXATION UNKNOWN PLATE; CUSTOM TEMPOROMANDIBULAR JOINT REPLACEMENT

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).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.

Event Description

It was reported that a patient underwent a tmj procedure on an unknown date.Subsequently, the patient is schedule to be revised.However, no revision procedure has been reported to date.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d1, g3, g6, h1, h2, h6 and h10.Upon receiving additional information, it was confirmed that the patient does not have a custom tmj implant at this time.The patient was implanted with a temporary plate until the custom device could be made.The plate has not malfunctioned or caused a serious injury; it has served its intended purpose.Therefore, this event is considered not reportable.The initial report submitted needs to be voided.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.

Event Description

This follow up is being submitted to relay additional information.

• Brand Name: UNKNOWN PLATE
• Type of Device: CUSTOM TEMPOROMANDIBULAR JOINT REPLACEMENT
• 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: 16761416
• MDR Text Key: 313500727
• Report Number: 0001032347-2023-00113
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/28/2023
• Supplement Dates FDA Received: 04/28/2023
• 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