MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	33680014
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Codes	Cyst(s) (1800); Inadequate Osseointegration (2646)
Date of Event	12/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient therefore an evaluation of the device cannot be performed.If additional information becomes available, it will be provided on a supplemental report.
Event or Problem Description
The digital stryker prophecy team reviewed a ct scan indicating that the patient may require revision surgery due to aseptic loosening of the tibial component.All bloodwork, including alpha defensin testing and cultures, has been negative for infection.The planned procedure involves converting the patient to a stemmed implant, necessitating the removal of both components.
Additional Manufacturer Narrative
Correction to d4(gtin).The reported event could be confirmed since the device was not returned for evaluation but with the provided ct scans alleged event could be confirmed.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.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.With the available ct scans a formal medical opinion was sought with the provided ct scan the aseptic loosening and subsidence of the tibial component can be confirmed here.There is clear radiolucence, cysts and a slight dislocation of the component visible in the ct scan.The talar component does not show relevant radiolucence and therefore loosening or migration cannot be confirmed.The underlying cause seems to be unclear although the surgeon brings up some potential points.Failure of total ankle replacement tar over time is a known complication.In case of a planned revision procedure a medical opinion aiming to determine the root cause of the failure is part of the internal investigation process.Sufficient radiological and clinical information must be provided to enable a meaningful clinical assessment and to identify possible causes of failure.In cases where a ct scan is the only available clinical source, this assessment is limited.No conclusive statement can be provided, because key clinical information e.G.Clinical status, exact symptoms and range of motion of the patient, assessment of the treating physician is missing.The root causes of radiographic findings such as radiolucent areas and bone cysts are often complex and multifactorial and cannot be determined scientifically without this decisive evidence.Due to these limitations, we are unable in such cases to provide statements about the patient, the procedure and or the device in relation to cause of the failure.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The digital stryker prophecy team reviewed a ct scan indicating that the patient may require revision surgery due to aseptic loosening of the tibial component.All bloodwork, including alpha defensin testing and cultures, has been negative for infection.The planned procedure involves converting the patient to a stemmed implant, necessitating the removal of both components.

• Brand Name: INFINITY ADAPTIS TIB SZ4LNG INFINITY ADAPTIS
• 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: 20995119
• Report Number: 3010667733-2024-01092
• Device Sequence Number: 4475834
• Product Code: HSN
• UDI-Device Identifier: 00889797069694
• UDI-Public: (01)00889797069694(11)231204(17)311204(10)1775564
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K181557
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 33680014
• Device Lot Number: 1775564
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/04/2023
• 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: Male