MAUDE Adverse Event Report: PROTEOR USA, IRVINE KINNEX 2.0 PROSTHETIC FOOT / ANKLE; COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT

Model Number KINNEX 2.0

Device Problems Product Quality Problem (1506); Mechanics Altered (2984); Physical Resistance/Sticking (4012)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 06/29/2022

Event Type  Injury  

Event Description

On (b)(6) 2022 i received a new lower limb prosthetic at my prosthetists clinic.The device included a new foot / ankle system: the freedom kinnex 2.0.The foot / ankle was calibrated and adjusted in the clinic by the salesman, (b)(6), from freedom innovations by proteor on that date.On (b)(6) 2022, seventy seven days from date of receiving new device, the medical foot / ankle device locked up mid-stride while i was walking on a level concrete side walk.Because the device locked up, i was catapulted forward with such force that my long leg tried to compensate, but the impact was with such force that my right (only) foot was broken in two places.The medical foot /ankle device remained locked and frozen in place as long as i had it after the fall.I do have a video of the faulty device.Because i am in amputee on the left, a broken foot on the right has caused several setbacks, and many increased difficult situations for daily living; months in a wheelchair, added physical limitations, and the need to start the process of getting a replacement prosthetic has got to be completed - 6 months post trauma.This was not the first time the device malfunctioned with me.I understand it also happened to others prior to my fall.Fcc id: (b)(4).

• Brand Name: KINNEX 2.0 PROSTHETIC FOOT / ANKLE
• Type of Device: COMPONENT, EXTERNAL, LIMB, ANKLE/FOOT
• Manufacturer (Section D): PROTEOR USA, IRVINE
• MDR Report Key: 16272708
• MDR Text Key: 308583231
• Report Number: MW5114578
• Device Sequence Number: 1
• Product Code: ISH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 01/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KINNEX 2.0
• Device Catalogue Number: F14-N2-07A24-SLA
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: CALCIUM; KRILL OIL ; MULTIVITAMIN; VITAMIN D; ZINC
• Patient Outcome(s): Disability; Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 102 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White