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

Catalog Number 33680021

Device Problem Migration (4003)

Patient Problems Failure of Implant (1924); Loss of Range of Motion (2032); Implant Pain (4561)

Event Date 08/04/2021

Event Type  Injury  

Manufacturer Narrative

Device 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 prosthesis appears to have subsided anteriorly.Patient states that she has soreness at the medial and lateral aspect of her right ankle.She notes that she has cut back on formal pt, attending once weekly due to soreness.She notes her concerns about overworking her ankle.Patient notes that she only began aggressive exercises the last 2 to 4 times she has last been at pt.Prior to surgical treatment patient notes stiffness and limited rom of her ankle.However, she notes improvement of ankle rom.

• Brand Name: INFINITY ADAPTIS 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: nathe hendricks ; 1023 cherry rd; memphis, TN 38117 ; 9014516318
• MDR Report Key: 12418138
• MDR Text Key: 270282783
• Report Number: 0001043534-2021-00169
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00889797101516
• UDI-Public: 00889797101516
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172633
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 33680021
• Device Lot Number: 1683232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/29/2020
• 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: 58 YR
• Patient Weight: 54