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

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/07/2020

Event Type  Injury  

Manufacturer Narrative

Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.

Event Description

It was reported that the patient underwent a total ankle replacement surgery.Allegedly, the talar component bread between 6 and 12 months post-op.There is currently no evidence of the component moving.

Manufacturer Narrative

H10: the products were not returned; however, radiographic images were provided.Review of the images does confirm inbone stems and tibial tray and an invision talar dome in-situ.Based on the angles, no complications are noted; however, it does appear one screw shaft is no longer visible in the (b)(6) nov radiograph.The angle of the radiograph could be a contributing factor of why it is no longer visible.And post-operative care, the implant, patient pathology and daily activity.

• Brand Name: INVISION 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
• MDR Report Key: 9665379
• MDR Text Key: 179296861
• Report Number: 1043534-2020-00027
• 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,Followup
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 01/07/2020
• Supplement Dates FDA Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1