MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SZ 3 LNG TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33650013

Device Problem Loss of Osseointegration (2408)

Patient Problems Cyst(s) (1800); Osteolysis (2377); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 11/19/2023

Event Type  Injury  

Manufacturer Narrative

Device is not available to be returned as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Event Description

It was reported that the patient has noticed pain and swelling of the ankle, 6 years post-op of a total ankle replacement.Ct scans show cystic changes in the tibia and talus with loss of bone density.It is possible that the patient may undergo a revision with removal of implants and changing to a ankle fusion with cadaver bone.Currently, the patient can walk on the ankle but wears a boot to limit the "shearing" action to the ankle.

• Brand Name: INFINITY TIBIAL TRAY SZ 3 LNG TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18942708
• MDR Text Key: 338148149
• Report Number: 3010667733-2024-00164
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122544
• UDI-Public: 00840420122544
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140749
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33650013
• Device Lot Number: 1592913
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White