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

Model Number	33650005
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Cyst(s) (1800); Bone Fracture(s) (1870); Inadequate Osseointegration (2646)
Date of Event	02/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Once the investigation has been completed any additional information will be reported in a supplemental report.Device remains implanted in patient.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Upon a ct scan it was noted that there was cystic formation around both tibial and talus components.Expected loosening of both components.No follow up procedures.
Event or Problem Description
It was reported that the patient underwent a total ankle replacement.Upon a ct scan it was noted that there was cystic formation around both tibial and talus components.Expected loosening of both components.No follow up procedures.
Additional Manufacturer Narrative
The reported event could be confirmed based on available medical record and health care expert¿s opinion.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.Formal medical opinion was sought from an experienced independent medical expert as below; ¿there are very large cysts around the tibial component.The remaining bone stock is poor and there seem to be some fracture lines around the cortex in the posterior part.All of this fits to the statements provided in the collateral information.The pe cannot be assessed directly in the ct-scan.There are no indirect signs of loosening or breakage, however.There are also large cysts in the talus.This is suggesting a loosening and needs revision as well.¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused by presence of large cysts around the tibial component and poor bone stock of the patient.As secondary observation fracture along the posterior part of cortex is also observed.If device is returned or any further information is provided, the investigation report will be reassessed.

• 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: 16492006
• Report Number: 3010667733-2023-00099
• Device Sequence Number: 5912484
• Product Code: HSN
• UDI-Device Identifier: 00840420122520
• UDI-Public: 00840420122520
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K140749
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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 Expiration Date: 04/02/2026
• Device Model Number: 33650005
• Device Catalogue Number: 33650005
• Device Lot Number: 1623788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2023
• Supplement Date Received by Manufacturer: 05/08/2023
• Initial Report FDA Received Date: 03/06/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/04/2018
• 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