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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aneurysm (1708); Swelling (2091)

Event Date 02/01/2016

Event Type  Injury  

Manufacturer Narrative

Literature citation: wooster, benjamin m.Et al.Iatrogenic arteriovenous fistula with associated pseudoaneurysm of posterior tibial artery after revision total ankle arthroplasty: a case report.The journal of foot and ankle surgery.2017; 56: 75-77.(b)(4).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, per wooster 2017 et al, "iatrogenic arteriovenous fistula with associated pseudoaneurysm of posterior tibial artery after revision total ankle arthroplasty: a case report", a patient presented with bilateral ankle pain and radiographs consistent with sever bilateral tibiotalar arthropathy.After undergoing conservative treatment, the patient had a total ankle arthroplasty on the right ankle and experienced significant improvement.Approximately 32 months post-op the patient underwent a total ankle arthroplasty on the left ankle.This surgery was complicated with aseptic loosening resulting in the patient undergoing a revision surgery approximately 16 months later.Approximately 1 week after surgery, the patient developed fullness in the medial aspect of the ankle with symptomatic paresthesia on the plantar aspect of his left foot.Duplex ultrasonography of the left ankle demonstrated an approximately 2-cm pulsatile mass at the level of the tarsal tunnel, with high frequency and low-resistance flow that was concerning for a posterior tibial artery aneurysm with an arteriovenous fistula.During a physical examination the patient demonstrated diffuse swelling of the left lower extremity with a pulsatile mass immediately posterior to the medial malleolus.A thrill was easily palpable over the mass.Sensation on the plantar aspect of the foot was grossly diminished.The posterior tibial and dorsalis pedis pulses were palpable, and the foot was warm and well perfused.The patient was taken back to the operating room 2 months after the revision surgery.A large aneurysmal dilation of the posterior tibial artery and an associated avf with the anterior vena comitantes was identified immediately proximal to the tarsal tunnel.No disruption of the tibial nerve was observed; however, a significant mass effect compression of the tibial nerve by the aneurysm was present.The avf was ligated and the pseudoaneurysm excised.The saphenous vein was harvested from the right lower extremity, reversed, and used to repair the defect with an end-to-end anastomosis.The tarsal tunnel was released to expose the extent of the damaged vessels, decompress the nerve, and provide access for the bypass graft.The immediate postoperative period was uneventful.At the 1- month follow-up visit, physical examination of the left lower extremity demonstrated a well-healing surgical incision with improvement in the preoperative swelling of the left foot.The posterior tibial artery and dorsalis pedis pulses were easily palpable.A hand-held doppler evaluation of the left ankle demonstrated patency of the graft.The sensation remained diminished in the tibial nerve distribution but had improved from the preoperative examination findings.

• Brand Name: INFINITY(R)
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; 38002
• Manufacturer Contact: timothy nickel ; 1023 cherry road; 901451-631
• MDR Report Key: 6331796
• MDR Text Key: 67480923
• Report Number: 1043534-2017-00019
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• 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
• Distributor Facility Aware Date: 01/24/2017
• Event Location: Hospital
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR