MAUDE Adverse Event Report: Ossur Iceland ehf Power Knee; Prosthetic knee

Catalog Number	PKA10003
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Concussion (2192)
Date of Event	09/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was walking outside his apartment complex, fell on the sidewalk, hit his head on the bricks behind him, and lost consciousness.

• Brand Name: Power Knee
• Common Device Name: Prosthetic knee
• Manufacturer (Section D): Ossur Iceland ehf; grjothals 5; reykjavik, 110 ; IC 110
• Manufacturer Contact: katla axelsdottir ; grjothals 5; reykjavik, 110 ; IC 110
• MDR Report Key: 50916668
• Report Number: 3003764610-2026-00005
• Device Sequence Number: 5803755
• Product Code: ISY
• UDI-Device Identifier: 05690967648749
• UDI-Public: 05690967648749
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (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): 09/28/2026

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: Lay User/Patient
• Device Catalogue Number: PKA10003
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/28/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown