MAUDE Adverse Event Report: HOCOMA AG Hocoma LokomatPro 6.3 FreeD AD; Powered exerciser

Catalog Number	63053
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	06/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
During the sixth session with the lokomat, the patient expressed a desire to increase her walking duration to 40 minutes.At approximately 35 minutes into the session, she began to exhibit fatigable clonus in the right calf muscle complex.Despite this, she remained able to achieve adequate foot clearance with the assistance of foot lifters.The patient reported that her foot felt "weird"; at that point, clonus was explained to her, and reassurance was provided that this can occur in the context of fatigue.As the patient was close to achieving her session goal and she was encouraged to continue walking safely with support, the decision was made to continue for a further 2-3 minutes before resting.At approximately 38 minutes, the lokomat stumble detection / cut-off feature activated, leaving the patient's right foot trapped behind her, positioned in plantar flexion and inversion within the foot lifter.
Additional Manufacturer Narrative
Patient was diagnosed with marked osteoporosis after the event, which is a contraindication for lokomat training.Lokomat stumbling detection worked as intended, but osteoporotic fibula did not withstand the occurring forces.The responsible healthcare professional involuntarily treated a contraindicated patient, which led to the incident.

• Brand Name: Hocoma LokomatPro 6.3 FreeD AD
• Common Device Name: Powered exerciser
• Manufacturer (Section D): HOCOMA AG; industriestrasse 4b; volketswil; zurich, CH-86 04; SZ CH-8604
• Manufacturer (Section G): HOCOMA AG; industriestrasse 4b; volketswil; zurich, CH-86 04; SZ CH-8604
• Manufacturer Contact: kevin walls ; 16958 long winding rd; morrison, CO 80465 ; +1(720)254-5756
• MDR Report Key: 50156509
• Report Number: 3003781275-2026-00002
• Device Sequence Number: 10632398
• Product Code: BXB
• UDI-Device Identifier: 07640174660414
• UDI-Public: 07640174660414
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: Health Professional
• Device Catalogue Number: 63053
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2026
• Initial Report FDA Received Date: 08/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 112 LB