MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TALAR DOME SZ 3 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number 33630023

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

Patient Problems Cyst(s) (1800); Osteopenia/ Osteoporosis (2651); Implant Pain (4561); Swelling/ Edema (4577)

Event Date 11/19/2023

Event Type  Injury  

Event Description

It was reported that the patient may need to undergo a revision surgery due to pain and swelling of the ankle.Ct scans show cystic changes in the tibia and talus with loss of bone density.Implants are currently still implanted, with plans for a revision soon - estimate in early june.The patient mentioned that the ankle will be removed and replaced with cadaver bone and will under go an ankle fusion.Patient was on a 10-day cruise in europe when he first experienced swelling.Patient states there was no traumatic event to his ankle.He notes he walked a bit more during the cruise (12,000 steps/day)compared to when he was at home (~8000 steps/day) but nothing significant.He notes no strenuous activities during the cruise that could have contributed to this event.Currently, the patient can walk on the ankle but wears a boot to limit the "shearing" action to the ankle.

Manufacturer Narrative

Based on the available information the device remains implanted therefore an evaluation of the device cannot be performed.A review of the device history is not possible because the lot number was not communicated.Should additional information become available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.

Event Description

It was reported that the patient may need to undergo a revision surgery due to pain and swelling of the ankle.Ct scans show cystic changes in the tibia and talus with loss of bone density.Implants are currently still implanted, with plans for a revision soon - estimate in early june.The patient mentioned that the ankle will be removed and replaced with cadaver bone and will under go an ankle fusion.Patient was on a 10-day cruise in europe when he first experienced swelling.Patient states there was no traumatic event to his ankle.He notes he walked a bit more during the cruise (12,000 steps/day)compared to when he was at home (~8000 steps/day) but nothing significant.He notes no strenuous activities during the cruise that could have contributed to this event.Currently, the patient can walk on the ankle but wears a boot to limit the "shearing" action to the ankle.

Manufacturer Narrative

The reported event could be confirmed based on available medical record and medical expert assessment.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.No indications of material, manufacturing or design related problems were found during the investigation.A review of the labeling did not indicate any abnormalities.Medical records and the radiology reports were also reviewed by the hcp, and there is nothing that really stands out, other than the cyst formation around implant in both tibia and talus.Upon further investigation of the ct scans by healthcare professionals the following was observed ¿all tar components look intact.There is significant periprosthetic cyst formation as well in the tibia as in the talus, which is an indication for revision (such bone loss is frequently progressive)¿ based on the investigation the root cause can be attributed to the patient related issue.The failure was caused due to significant periprosthetic cyst formation in tibia as well as talus which is an indication for revision.Also, all the tar components are assessed as fixed by the hcp.If device is returned or any further information is provided, the investigation report will be reassessed.

• Brand Name: INFINITY TALAR DOME SZ 3 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: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 18828295
• MDR Text Key: 336802988
• Report Number: 3010667733-2024-00133
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00840420122049
• UDI-Public: 00840420122049
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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: 33630023
• Device Lot Number: 1591126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/06/2024
• Initial Date FDA Received: 03/04/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/09/2017
• 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): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG