MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY TIBIAL TRAY SIZE 5 TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33650005
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Osteolysis (2377); Inadequate Osseointegration (2646)
Date of Event	07/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient had an total ankle replacement about 1 year ago and seems to be experiencing non-integration of his tibial compartment.He has noticed sinking in the posterior part of the tibia, as well as in the anterior part.
Additional Manufacturer Narrative
Device will not be returned as it remains implanted in the patient.If additional information becomes available, it will be provided on a supplemental report.H3 other text : device remains implanted in patient.
Additional Manufacturer Narrative
The reported event could be confirmed since x-ray images were provided and shows loosening of the tibial component.Upon further investigation of the x-ray images by healthcare professionals the following was observed: "there are three pairs of x-ray available for examination.The first x-ray show the pre-implant situation with a clear advanced arthrosis of the upper ankle joint.There is also an arthrosis of the lower ankle joint visible, and the arthrosis visible preoperatively regarding the talonavicular joint shows a remarkable progress in the consecutive x-ray after 1.5 years.The next image shows the situation after the implantation of the tar after three months.There is no loosening or migration visible neither in the tibia, nor in the talus.The pe looks fine.After 1.5 years the tibial component shows clear radiolucence posterior and lateral, there is a bit of radiolucence anteriorly.Therefore loosening can be confirmed.There is no clear evidence for loosening of the pe or the talar component." based on investigation, the root cause was attributed to a patient related issue.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.The instructions for use were reviewed and states: "dislocation and subluxation of prosthetic components can result from improper positioning and/ or migration of the components.Muscle and fibrous tissue laxity can also contribute to these conditions.Prosthetic components can loosen or migrate due to trauma or loss of fixation." 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 reassessed.
Event or Problem Description
It was reported that patient had an total ankle replacement about 1 year ago and seems to be experiencing non-integration of his tibial compartment.He has noticed sinking in the posterior part of the tibia, as well as in the anterior part.

• Brand Name: INFINITY TIBIAL TRAY SIZE 5 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: 17415508
• Report Number: 3010667733-2023-00420
• Device Sequence Number: 7135462
• Product Code: HSN
• UDI-Device Identifier: 00840420122520
• UDI-Public: 00840420122520
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2023

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 Catalogue Number: 33650005
• Device Lot Number: 1698667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2023
• Supplement Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 07/28/2023
• Supplement Report FDA Received Date: 10/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2021
• 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: Unknown