MAUDE Adverse Event Report: TMJ CONCEPTS PROSTHETIC JAW

Device Problem Biofilm coating in Device (1062)

Patient Problems Unspecified Infection (1930); Pain (1994); Swelling (2091)

Event Type  Injury  

Event Description

I have had both tmj's replaced.One in 11/12 and the other 4/13.The last device implanted became increasing sore and swollen over the months following.It was determined through scans that there was fluid surrounding the implant.Because my blood markers showed no signs of infections and after a lengthy conversation with my surgeon, i decide to tough it out for a few more months (8/13) and see if the fluid dissipated.When i returned to the (b)(6) clinic for scans in (b)(6) 2013 the screws in the implant were nearly 100% displaced due to biofilm infection that was completely coating the entire device.I then received 6 weeks of iv antibiotics and am currently awaiting the completion and implantation of my new joint.This will hopefully occurs within a month or two.My blood tests continue to suggest no infection is present.But they were not a very reliable marker as it turns out.Chances are it was infected from the date of implantation.I love my surgeon and trust him 100% to be doing whatever is necessary to relieve some of my pain and restore function to my joint.I feel very fortunate to only live two hours from the (b)(6) clinic in (b)(6).They are a not for profit hospital so not only have i received excellent care with the latest technology, but i know they are not doing unnecessary surgeries to increase their bottom line.

• Brand Name: PROSTHETIC JAW
• Type of Device: PROSTHETIC JAW
• Manufacturer (Section D): TMJ CONCEPTS
• MDR Report Key: 3704973
• MDR Text Key: 4338157
• Report Number: MW5035232
• Device Sequence Number: 1
• Product Code: LZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 54 YR
• Patient Weight: 52