MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY POLY SZ 3 8MM TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33653308
Medical Device Problem Codes	Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cyst(s) (1800); Osteopenia/ Osteoporosis (2651); Implant Pain (4561); Swelling/ Edema (4577)
Date of Event	11/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient has noticed pain and swelling of the ankle, 6 years post-op of a total ankle replacement.Ct scans show cystic changes in the tibia and talus with loss of bone density.It is possible that the patient may undergo a revision with removal of implants and changing to a ankle fusion with cadaver bone.Currently, the patient can walk on the ankle but wears a boot to limit the "shearing" action to the ankle.
Additional Manufacturer Narrative
Device is not available to be returned as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.
Additional 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.
Event or Problem Description
It was reported that the patient has noticed pain and swelling of the ankle, 6 years post-op of a total ankle replacement.Ct scans show cystic changes in the tibia and talus with loss of bone density.It is possible that the patient may undergo a revision with removal of implants and changing to a ankle fusion with cadaver bone.Currently, the patient can walk on the ankle but wears a boot to limit the "shearing" action to the ankle.

• Brand Name: INFINITY POLY SZ 3 8MM TOTAL ANKLE SYSTEM
• Common Device Name: 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: 18942709
• Report Number: 3010667733-2024-00165
• Device Sequence Number: 16886458
• Product Code: HSN
• UDI-Device Identifier: 00840420122711
• UDI-Public: 00840420122711
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/20/2024
• Device Catalogue Number: 33653308
• Device Lot Number: 1584088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/26/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 77 KG
• Patient Race: White