MAUDE Adverse Event Report: HOCOMA AG HOCOMA; LOKOMATPRO L6.2 FREED KOMBI

Catalog Number	30682
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	05/22/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Loosing a shoe is hardly possible when user sticks to the best practice for this device.It leads us to the conclusion that the footlifters of the device were not used despite being recommended best practice by the manufacturer.
Event or Problem Description
Patient looses shoe and drags toes on treadmill of robotic rehabilitation device.Lokomat was stopped by therapist and training continued.X-ray on (b)(6) 26.Revealed distal fractures of tibia and fibula.

• Brand Name: HOCOMA
• Common Device Name: LOKOMATPRO L6.2 FREED KOMBI
• 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 ; 33 golden eagle lane; littleton, CO 80127 ; 7202545756
• MDR Report Key: 25318307
• Report Number: 3003781275-2026-00001
• Device Sequence Number: 9938483
• Product Code: BXB
• UDI-Device Identifier: 07640174660155
• UDI-Public: 07640174660155
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 05/28/2026

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: 30682
• 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: 05/27/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2022
• 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: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 62 KG