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

Model Number 33650013

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

Patient Problems Pain (1994); Loss of Range of Motion (2032); Discomfort (2330); Ambulation Difficulties (2544)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient underwent a right ankle arthroplasty about a year ago.The patient has not done great and has pain in the ankle and stiffness with range of motion.The patient came in for a gutter debridement.Patient has pain on the medial and lateral malleoli.It seems to limit walking.It was discussed doing a debridement of the gutters, partial excision of the medial malleoli and the talar region.

Manufacturer Narrative

The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were provided.The device inspection was not possible as the product was not returned for investigation.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.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.If device is returned or any further information is provided, the investigation report will be reassessed.

Event Description

It was reported that the patient underwent a right ankle arthroplasty about a year ago.The patient has not done great and has pain in the ankle and stiffness with range of motion.The patient came in for a gutter debridement.Patient has pain on the medial and lateral malleoli.It seems to limit walking.It was discussed doing a debridement of the gutters, partial excision of the medial malleoli and the talar region.

• 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: 12318356
• MDR Text Key: 266395095
• Report Number: 0001043534-2021-00146
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122544
• UDI-Public: 00840420122544
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 33650013
• Device Catalogue Number: 33650013
• Device Lot Number: 1619034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2018
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 104 KG