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

Device Problem Migration (4003)

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

Event Date 09/30/2019

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

Allegedly, the patient underwent a total ankle replacement.Sometime post-op, it was found that the implant has subsided.No revision has taken or place or been scheduled at this time.

Manufacturer Narrative

Additional info: d11: talar dome;tibial tray; tibial mid and top stem tibial base stem.H6: images were provided that showed there was a total ankle replacement.

• Brand Name: INBONE 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: 9247828
• MDR Text Key: 170141608
• Report Number: 1043534-2019-00184
• 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: 09/30/2019

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: 09/30/2019
• Initial Date FDA Received: 10/28/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 03/12/2020
• Patient Sequence Number: 1