MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. INFINITY® TALAR DOME SZ 2 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Edema (1820); Pain (1994); Swelling (2091)

Event Date 02/23/2017

Event Type  Injury  

Manufacturer Narrative

The suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.Part # 33630022, lot 1581431; part # 33650002, lot 1583031; part # 33652206, lot 1541546.Part # 33630022, lot 1581431 is 09/28/2016; part # 33650002, lot 1583031 is 09/26/2016; part # 33652206, lot 1541546 is 05/01/2014.Eval: varus failure.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 2 months prior to total ankle replacement surgery, the patient had increased ankle pain.The patient had remote history of right ankle fractures.After conservative treatment failed, the patient underwent surgery.A few weeks after surgery, it was noticed that the ankle had increased swelling and edema.Two months post-op, varus fail of implant and a medial mal fracture were noted on films.The dpm called it a stress riser medial mal fracture.Three months post-op, the patient underwent an orif to treat the medial mal fracture.The dpm suggested on op notes that the fracture was a result from rom with physical therapy.

Manufacturer Narrative

The products were not returned; therefore, product analysis cannot be performed.Radiographic images from before the initial total ankle surgery and postoperative images after the medical intervention for the orif were provided.The images show an infinity total ankle, a screw through the medial malleolus into the tibia, and a plate with screws along the tibia.Without images taken immediately postoperative from the initial total ankle surgery and/or progressive image taken since the initial surgery, it is difficult to draw conclusions related to position.

• Brand Name: INFINITY® TALAR DOME SZ 2 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: 1023 cherry road; memphis, TN 38117 ; 9014516318
• MDR Report Key: 7112911
• MDR Text Key: 94704343
• Report Number: 1043534-2017-00116
• 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: 11/15/2017

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?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/15/2017
• Event Location: Home
• Initial Date Manufacturer Received: 11/15/2017
• Initial Date FDA Received: 12/13/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 12/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: POLY; TALAR DOME; TIBIAL TRAY
• Patient Outcome(s): Other