MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE TALAR DOME SZ 2 SULCUS; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	220220902
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003)
Health Effect - Clinical Code	Inadequate Osseointegration (2646)
Date of Event	11/06/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery due to tibial tray and talus showing collapse.
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.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available medical records and assessment of health care professionals.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.Upon further investigation of the ct scans by healthcare professionals the following was observed: after reviewing hcp opinion and surgeon¿s feedback we can conclude that the tibial component shows clear radiolucence , small cysts and subsidence.Therefore, loosening and migration can be confirmed.Talar components smaller radiolucence around the pegs and little bit of condensed bone at the posterior implant.The overall bone quality is reduced.Loosening can be confirmed, but there is no clear sign of migration.Based on investigation, the root cause was attributed to a patient related issue.The failure is detected by the radiolucence ,cavities around tibial and talar components.As a result, subsidence is observed in tibial part while loosening may occurred in talar component.If device is returned or any further information is provided, the investigation report 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 due to tibial tray and talus showing collapse.

• Brand Name: INBONE TALAR DOME SZ 2 SULCUS
• 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: 18239076
• Report Number: 3010667733-2023-00730
• Device Sequence Number: 6983364
• Product Code: HSN
• UDI-Device Identifier: 00840420124210
• UDI-Public: 00840420124210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K100886
• 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): 01/26/2024

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: 220220902
• Device Lot Number: 1689221
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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 Age: 75 YR
• Patient Sex: Male