MAUDE Adverse Event Report: Stryker GmbH Smart Toe II Intramedullary Arthrodesis Implant 19mm / 0Deg angle for; Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer

Catalog Number	ST019P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Deformity/ Disfigurement (2360); Ambulation or Postural Difficulties (2544); Joint Impingement (4834)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information has been requested and, if received, will be provided in a supplemental report.
Event or Problem Description
The patient reported a history of multiple left foot surgeries involving the toe adjacent to the great toe, including two revision procedures.The patient stated the smart toe implant appears crooked, and the toe intermittently bends and becomes stuck.The patient described the condition as painful, causing difficulty walking, requiring flat-footed ambulation, and resulting in pain with pressure during walking.

• Brand Name: Smart Toe II Intramedullary Arthrodesis Implant 19mm / 0Deg angle for
• Common Device Name: Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
• Manufacturer (Section D): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): Stryker GmbH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer Contact: dannielle stap ; 325 corporate drive; mahwah, NJ 07430 ; +1(201)831-5000
• MDR Report Key: 24299101
• Report Number: 0008031020-2026-00138
• Device Sequence Number: 10153987
• Product Code: HSN
• UDI-Device Identifier: 07613252263340
• UDI-Public: (01)07613252263340(17)260430(10)H39031
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K190402
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2026

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
• Device Expiration Date: 04/30/2026
• Device Catalogue Number: ST019P
• Device Lot Number: H39031
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 07/01/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 07/27/2026
• Date Device Manufactured: 05/26/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female