MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC INBONE STEM TIBIAL MID SIZE 14MM RIGHT AND LEFT; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	200010901
Medical Device Problem Codes	Osseointegration Problem (3003); Migration (4003); Implant subsidence (4078)
Health Effect - Clinical Codes	Extraskeletal ossification (1428); Pain (1994); Inadequate Osseointegration (2646); Limb Fracture (4518)
Date of Event	11/12/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient has multiple fractures in the tibia and may require a revision surgery due to subsidence of the tibial component and the implant tilting into varus, causing significant pain.
Additional Manufacturer Narrative
Once the investigation is completed, any additional information will be reported in a supplemental report.
Event or Problem Description
The digital stryker prophecy team received a ct scan indicating that the patient has multiple fractures in the tibia and may require a revision surgery due to subsidence of the tibial component and the implant tilting into varus, causing significant pain.
Additional Manufacturer Narrative
Correction - h6 (device code).The reported event could be confirmed, as loosening and migration of the tibial component were evident on the provided ct scan.In addition, protrusion of the tibial cortex was observed, which led to bone formation at the tip of the tibial stem.This finding could be assessed as a periprosthetic fracture or, at a minimum, bone damage.Device inspection was not possible because the product was not returned for investigation.A review of the device history record for the reported lot did not identify any abnormalities.Therefore, no corrective actions are required at this time.A review of the labeling did not reveal any abnormalities.No indications of material-, manufacturing-, or design-related issues were identified during the investigation.Further review of the ct scans by healthcare professionals confirmed loosening and migration of the tibial component.Protrusion of the tibial cortex with associated bone formation at the tip of the tibial stem was also noted, which may represent a periprosthetic fracture or bone damage.The talar component appeared unremarkable; however, some radiolucency was present.The underlying cause of the failure could not be clearly determined, although poor bone quality was identified as a potential patient-related contributing factor.Failure of total ankle replacement over time is a known complication.In cases of planned revision procedures, a medical assessment aimed at determining the root cause of failure is part of the internal investigation process.Adequate radiological and clinical information must be provided to enable a meaningful clinical assessment and to identify potential causes of failure.When a ct scan is the sole source of clinical information, the assessment is limited.As key clinical information, such as the patient¿s clinical status, exact symptoms, range of motion, and the treating physician¿s assessment, was not available, no conclusive determination could be made.The causes of radiographic findings, including radiolucent areas and bone cysts, are often complex and multifactorial and cannot be scientifically determined without this essential information.Due to these limitations, it is not possible to provide definitive statements regarding the patient, the procedure, or the device in relation to the cause of failure.Based on the available information, the issue most likely occurred due to patient-related factors, specifically poor bone quality.Additional details regarding the complaint event and the affected device would be required to determine the root cause.If the device is returned or further information becomes available, the investigation will be reassessed.

• Brand Name: INBONE STEM TIBIAL MID SIZE 14MM RIGHT AND LEFT
• 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: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 23771852
• Report Number: 3010667733-2025-01493
• Device Sequence Number: 21254562
• Product Code: HSN
• UDI-Device Identifier: 00840420123855
• UDI-Public: (01)00840420123855(11)241007(17)321007(10)1796510
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K051023
• 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): 05/04/2026

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: 200010901
• Device Lot Number: 1796510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/07/2024
• 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