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

Model Number 33650014

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Necrosis (1971)

Event Date 03/09/2017

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, it was reported that the patient underwent a total ankle replacement surgery.Approximately four months post-op the patient underwent a revision due to avascular necrosis of the anterior aspect of the tibia.No additional patient complications were reported.

Manufacturer Narrative

Visual examination of the returned devices does not show any overall gross deformation.The poly was returned still seated on the tibial tray.Visual examination the porous surface of the talar dome and tibial tray does exhibit a few areas of apparent bone attachment.Radiographic images were provided, from review of the images it does appear that the tibial tray had subsided/loosened.

• Brand Name: INFINITY®
• 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: timothy nickel ; 1023 cherry road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 6456296
• MDR Text Key: 71597326
• Report Number: 1043534-2017-00036
• Device Sequence Number: 1
• Product Code: HSN
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/21/2024
• Device Model Number: 33650014
• Device Lot Number: 1573348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/09/2017
• Event Location: Hospital
• Date Manufacturer Received: 03/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• 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): Required Intervention
• Patient Age: 62 YR