MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 2 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	33650002
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	05/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the available information the device will not be returned 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 : the device remains implanted in the patient.
Event or Problem Description
I would report the event like this: it was reported that the patient will need to undergo a revision surgery due to movement of the tibial tray.The surgeon plans on revising the tibial tray and switching the poly.If the talar implant needs to be replaced it will be switched but at this time the surgeon is not clear if that will be necessary.
Additional Manufacturer Narrative
Please note the corrections made to the h6 device code and the clinical signs code: the reported event was confirmed, based on available medical record and health care professionals.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.Upon further investigation of the ct scans by healthcare professionals the following was observed: the tibial component shows some clear loosening with radiolucency around the component, with cavities and cysts.However, migration cannot be confirmed with the provided ct.There is no information on infection.The pe cannot be assessed directly and there is no indirect proof of loosening or breakage.There is some radiolucency especially around the pegs and the anterior part seems to show subsidence, but there are artefacts in that area which do not allow for a clear statement.Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by cyst and cavities which results in loosening around tibial component.If the device is returned or any further information is provided, the investigation report will be reassessed.
Event or Problem Description
I would report the event like this: it was reported that the patient will need to undergo a revision surgery due to movement of the tibial tray.The surgeon plans on revising the tibial tray and switching the poly.If the talar implant needs to be replaced it will be switched but at this time the surgeon is not clear if that will be necessary.

• Brand Name: INFINITY TIBIAL TRAY SIZE 2 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: 17036969
• Report Number: 3010667733-2023-00298
• Device Sequence Number: 12391091
• Product Code: HSN
• UDI-Device Identifier: 00840420122490
• UDI-Public: 00840420122490
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2023

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 Model Number: 33650002
• Device Catalogue Number: 33650002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/04/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Female