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

Catalog Number UNK_WWA

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

Patient Problem Pain (1994)

Event Date 06/01/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned at time of this report as it is still implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.Device not available remains implanted.

Event Description

It was reported that the patient underwent a total ankle replacement surgical procedure.Allegedly, the patient presented in the surgeon's clinic with pain and wanted him to revise his ankle.The patient will undergo a revision surgery.

Event Description

It was reported that the patient underwent a total ankle replacement surgical procedure.Allegedly, the patient presented in the surgeon's clinic with pain and wanted him to revise his ankle.The patient will undergo a revision surgery.

Manufacturer Narrative

The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Imaging provided was not of sufficient quality for any conclusion to be drawn.There are many clinical factors that can affect the results of any surgery, such as surgical technique, pre-operative and post-operative care, the implant, patient pathology and daily activity.The instructions for use provided with these devices does indicate that intraoperative, early, and late postoperative complications can include pain.More detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.

• Brand Name: INFINITY¿ 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: 12076927
• MDR Text Key: 258709079
• Report Number: 0001043534-2021-00114
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/02/2021

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?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNK_WWA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/28/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/02/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention