MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE; JOINT, TEMPOROMANDIBULAR, IMPLANT

Model Number N/A

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)

Patient Problems Implant Pain (4561); Swelling/ Edema (4577)

Event Date 04/23/2022

Event Type  Injury  

Event Description

It was reported that after a temporomandibular joint procedure that the patient experienced a revision due to pain and swelling.Surgeon suspects previous surgeon placed joint too close to the ear canal.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).Concomitant medical products: medical devices: tmj system mandibular component left standard offset titanium 50mm / 9 hole, item# 24-6551ti, lot# 296060.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

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.D10 ¿ medical products.Tmj system left standard mandibular component 50mm / 9 hole, item #24-6551, lot #296060.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.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.This report is being submitted to update additional information in section b4, b5, d4, d10, g3, g6, h2, h3, h4, h6 and h10.

• Brand Name: TMJ SYSTEM LEFT STANDARD OFFSET MANDIBULAR COMPONENT 50MM / 9 HOLE
• 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 ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 14455311
• MDR Text Key: 292164524
• Report Number: 0001032347-2022-00136
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020016
• 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: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• 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: 24-6561
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention