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

Model Number 33630022

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

Patient Problems Inflammation (1932); Implant Pain (4561)

Event Date 11/03/2021

Event Type  Injury  

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery due to pain and inflammation.

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.

Manufacturer Narrative

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.The reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.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.A inspection of the x-ray's has shown that those are in a poor quality, based on this we are not able to do any statement.A inspection of the received picture has shown that the three explanted articles are visible, as tibial tray, talar dome and poly.The implants visible do not show any signs of a malfunction.Based on this we are not able to do any further statement.A review of the device history for the reported lot did not indicate any abnormalities.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 re-assessed.

Event Description

It was reported that the patient underwent a total ankle replacement.Allegedly, the patient may need to undergo a revision surgery due to pain and inflammation.

• Brand Name: INFINITY¿ TOTAL ANKLE SYSTEM
• Type of Device: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• 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: 13122259
• MDR Text Key: 283103711
• Report Number: 3010667733-2021-00032
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122032
• UDI-Public: 00840420122032
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K123954
• 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: 03/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 33630022
• Device Catalogue Number: 33630022
• Device Lot Number: 1633051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2018
• 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; Hospitalization
• Patient Age: 61 YR
• Patient Sex: Female