MAUDE Adverse Event Report: STRYKER CORPORATION / TMJ SOLUTIONS, LLC. TMJ TOTAL JOINT REPLACEMENT; JOINT, TEMPOROMANDIBULAR, IMPLANT

Patient Problems Foreign Body Reaction (1868); Hearing Impairment (1881); Failure of Implant (1924); Unspecified Infection (1930); Pain (1994); Tachycardia (2095); Tinnitus (2103); Burning Sensation (2146); Localized Skin Lesion (4542)

Event Date 08/01/2020

Event Type  Injury  

Event Description

After implantation of tmj(temporomandibular joints) total joint implants made by (b)(6), i developed skin lesions, oral cavity infections, lost teeth, heterotrophic bone growth and ankylosis, tinnitus, intractable pain, histamine response, loss of hearing in right ear, burning mouth syndrome, pots(postural tachycardia syndrome).Surgery revealed ankylosis and required debridement and removal of the right joint.I was wired shut from (b)(6) 2023.

• Brand Name: TMJ TOTAL JOINT REPLACEMENT
• Type of Device: JOINT, TEMPOROMANDIBULAR, IMPLANT
• Manufacturer (Section D): STRYKER CORPORATION / TMJ SOLUTIONS, LLC.
• MDR Report Key: 18563872
• MDR Text Key: 333601748
• Report Number: MW5150635
• Device Sequence Number: 1
• Product Code: LZD
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White