MAUDE Adverse Event Report: BIOMET MICROFIXATION TMJ SM RT FOSSA COMP; TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS

Catalog Number 24-6562

Device Problem Osseointegration Problem (3003)

Patient Problem Ossification (1428)

Event Date 07/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).Concomitant medical products: 45mm rt narrow mand cat# 01-6545 lot# 503660a.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 - 2021 - 00417.

Event Description

It was reported that a patient underwent a revision procedure approximately 7 years postimplantation of a tmj device due to heterotopic bone formation surrounding the implant.Attempts to obtain additional information have been made; however, no more is available.

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 records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

Event Description

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

• Brand Name: TMJ SM RT FOSSA COMP
• Type of Device: TOTAL TEMPOROMANDIBULAR JOINT PROSTHESIS
• 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 delaney ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 12446507
• MDR Text Key: 270534502
• Report Number: 0001032347-2021-00418
• 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: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

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 Expiration Date: 03/01/2019
• Device Catalogue Number: 24-6562
• Device Lot Number: 53280A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/18/2021
• Initial Date FDA Received: 09/09/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Hospitalization; Required Intervention