MAUDE Adverse Event Report: STRYKER LEIBINGER GMBH & CO. KG. TMJ CONCEPTS/STRYKER JAW IMPLANT; PLATE BONE

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

Patient Problems Itching Sensation (1943); Pain (1994); Rash (2033); Swelling/ Edema (4577)

Event Date 11/01/2021

Event Type  Injury  

Event Description

I had a total jaw replacement surgery in (b)(6) 2017.It was done with tmj(temporomandibular) concepts/stryker.I found out through a metal testing that i was allergic to nickel.I had a replacement surgery done (b)(6) 2020 with all titanium part.I did good for a year in a half.Around (b)(6) 2021 i was having problems with it.Pain, swelling, itching, rash.I developed facial palsy on my right side and still haven't totally recovered.I went back to my surgeon to see why i was having problems again.No answers.I contacted tmj concepts/stryker and they said i received a total titanium joint that has no nickel in it.The symptoms are really similar to the original symptoms to the nickel allergy so not sure if there are any traces of nickel.I have been to many doctors to see why i am having these issues and they are getting worse.I sent info to mayo clinic and they can't see anything.I went to a dr at the (b)(6) and he couldn't find why i have problems.I have been to neurologists and allergist with no help.I have had an mri, ct and various blood tests.I am not sure if there is anything you can do to help me but i need to know where to look further.I am not sure if my body is rejecting the joint or if there is something else i am allergic to.The allergist did testing and it only shows nickel.I have exhausted all avenues that i know of and can't find any help or anyone with similar problems.Any suggestions from you would be greatly appreciated.

• Brand Name: TMJ CONCEPTS/STRYKER JAW IMPLANT
• Type of Device: PLATE BONE
• Manufacturer (Section D): STRYKER LEIBINGER GMBH & CO. KG.
• MDR Report Key: 16380850
• MDR Text Key: 309744584
• Report Number: MW5114966
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• 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: 02/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White