MAUDE Adverse Event Report: BIOMET MICROFIXATION MEDIUM LEFT INVST FOSSA COMP; TMJ

Model Number N/A

Device Problems Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Adhesion(s) (1695); Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)

Event Date 01/28/2014

Event Type  Injury  

Event Description

A tmj revision surgery due to ankylosis was reported.

Manufacturer Narrative

The warnings in the package insert state this type of event can occur.Without a product return, no product evaluation is able to be conducted.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.

Manufacturer Narrative

The device was returned and analyzed as part of (b)(6).This supplemental report is late information received from (b)(6), which was reported as expected to the ps 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, intra-operative observations note, ¿fibrous scar tissue in the region of the fossa and around the condylar prosthesis.¿ these findings probably contributed to device failure.This is report 1 of 2 for the same event.Report 2 of 2 is reported on mfr #0001032347-2014-00052-1.

• Brand Name: MEDIUM LEFT INVST FOSSA COMP
• Type of Device: TMJ
• 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: 3649027
• MDR Text Key: 4182701
• Report Number: 0001032347-2014-00051
• 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: Study,Health Professional,health professional,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2003
• Device Model Number: N/A
• Device Catalogue Number: 01-6561
• Device Lot Number: 261390
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/1998
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR