MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INVISION TALAR DOME SIZE 2 STD; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	60012002
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Deformity/ Disfigurement (2360); Inadequate Osseointegration (2646)
Date of Event	12/15/2023
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.H3 other text : device remains implanted in patient.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery because the talar implant subsided on the posterior lateral side leading the heel to fall into valgus.The patient also has some heterotopic ossification that needs to be removed.
Additional Manufacturer Narrative
The reported event could be confirmed since images of ct scans were provided and shows subsidence of the talar component.Upon further investigation of the ct scans by healthcare professionals the following was observed: ¿there is no clear radiolucence or cysts visible.However, the ct supports the reported statement by the hcp, that there is a dorsolateral subsidence.That can be seen when scrolling through the ap-view.There is the condensed bone below the component and thus some subsidence/migration visible.¿ based on investigation, the root cause was attributed to a patient related issue.As reported by the surgeon, some underlying hindfoot valgus might have contributed to the problem.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.¿ 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 received a ct scan indicating that the patient may require a revision surgery because the talar implant subsided on the posterior lateral side leading the heel to fall into valgus.The patient also has some heterotopic ossification that needs to be removed.

• Brand Name: INVISION TALAR DOME SIZE 2 STD
• 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: 18479809
• Report Number: 3010667733-2024-00012
• Device Sequence Number: 6924483
• Product Code: HSN
• UDI-Device Identifier: 00840420193766
• UDI-Public: 00840420193766
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171067
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2024

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 Catalogue Number: 60012002
• Device Lot Number: 1698937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2022
• 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