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	Loss of Osseointegration (2408); Insufficient Device Problem Information (3190); Migration (4003)
Health Effect - Clinical Codes	Inadequate Osseointegration (2646); Insufficient Information (4580)
Date of Event	10/31/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available for evaluation as it remains implanted in the patient.A review of the device history is not possible because the lot number was not communicated.If additional information becomes available, it will be provided on 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 of both tibial and talar components for reasons that are not available at the time of this report.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient may require a revision surgery of both tibial and talar components for reasons that are not available at the time of this report.
Additional Manufacturer Narrative
The reported event could be confirmed, based on available ct scans and medical expert 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.Upon further investigation of the ct scans by healthcare professionals the following was observed: tibial components are intact.Some radiolucency around the mid stem and base stem components, not around the top stem.No signs of gross wear of pe observed.Talar component has subsided.Ct scan show overall poor bone quality after subtalar arthrodesis (fusion).Based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone stock that contributed to the lack of osteointegration of the talar construct resulting in subsidence.If device is returned or any further information is provided, the investigation report will be reassessed.

• 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: 18196505
• Report Number: 3010667733-2023-00715
• Device Sequence Number: 6403334
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: 1677483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2020
• 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 Sex: Male