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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/23/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.Two radiographic images were provided that depict infinity devices in-situ.It does appear to show some lucencies around the tibial tray pegs, but doesn't appear to have shifted; however, immediate postop images were not provided for comparison.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, during a 3 year follow-up appointment, the patient's x-ray showed voids around the pegs of the talar implant.Physician believes that the implant may be loose.The physician does not believe it is an implant issue.The patient is a roofer and puts extreme load on the implants.

• Brand Name: INFINITY TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: matthew parrish ; 1023 cherry rd; memphis, TN 38117
• MDR Report Key: 11201354
• MDR Text Key: 227750254
• Report Number: 1043534-2021-00009
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 12/23/2020

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2018
• 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