MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. WRIGHT TOTAL ANKLE REPLACEMENT IMPLANT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Patient Problems Pain (1994); Swelling/ Edema (4577); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/19/2023

Event Type  Injury  

Event Description

My left ankle was replaced around (b)(6) 2017 with a wright implant.In (b)(6) 2023 i noticed pain and swelling of the ankle.Ct scans show cystic changes in the tibia and talus with loss of bone density.I do not know if the plastic component of the implant has broken or not.

• Brand Name: WRIGHT TOTAL ANKLE REPLACEMENT IMPLANT
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.
• MDR Report Key: 18552299
• MDR Text Key: 333517062
• Report Number: MW5150590
• Device Sequence Number: 1
• Product Code: HSN
• 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: 01/17/2024

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?: Yes
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/19/2024
• Patient Sequence Number: 1
• Treatment: ENALAPRIL.; HYDRAZINE.; IBUPROFEN.; TRAMADOL.
• Patient Outcome(s): Disability
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White