MAUDE Adverse Event Report: BIOMET MICROFIXATION 50 MM RIGHT STANDARD MANDIBLE; MANDIBLE IMPLANT

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Swelling (2091)

Event Date 12/26/2013

Event Type  Injury  

Event Description

A tmj revision surgery due to pain and swelling.

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.The device is enrolled in the tmj clinical study and will be evaluated by the clinical research department.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Device enrolled in tmj clinical study.

Manufacturer Narrative

The device was returned and analyzed as part of the (b)(6) study.This supplemental report is late information received from the (b)(6) study, which was reported as expected to the (b)(6) studies program, but inadvertently not recognized as 803 reportable until after the close of the study.According to the study: no failure mode was identified.Additionally, the patient had the biomet replacement device for over 8 years without indication of failure.She suffered a blunt facial trauma that led to a staged removal of the fossa first, and then the mandible component associated to a local neuroma formation.Evidence of dense fibrous tissue with focal ossification around the mandible component was verified by tissue biopsy.

• Brand Name: 50 MM RIGHT STANDARD MANDIBLE
• Type of Device: MANDIBLE 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: michelle cole ; 1520 tradeport drive; jacksonville, FL 32218 ; 9047414400
• MDR Report Key: 3698628
• MDR Text Key: 20716811
• Report Number: 0001032347-2014-00082
• Device Sequence Number: 1
• Product Code: LZD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP020016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/29/2014

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: 12/01/2005
• Device Model Number: N/A
• Device Catalogue Number: 24-6550
• Device Lot Number: 123481
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2014
• Initial Date FDA Received: 03/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2003
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR