MAUDE Adverse Event Report: VIONIC VIONIC SHOES; ORTHOSIS, CORRECTIVE SHOE

Model Number 335ADLEY/ASR-1437

Device Problems Device Markings/Labelling Problem (2911); Material Distortion (2977); Material Twisted/Bent (2981)

Patient Problem Pain (1994)

Event Date 01/19/2017

Event Type  Injury  

Event Description

I purchased two pairs of vionic sneakers from (b)(6).On (b)(6) 2017 i tried them on to make sure i liked the fit.They did not feel right on my foot.I decided to wear them to the grocery - it would be quick and maybe could tell more about the shoes.I walked from the grocery store parking lot which is small and before i was half way into the store i had pain in my left ankle and my left knee popped, my right knee had terrible pain too but did not pop.I was hanging onto the shelving to not fall down which drew the attention from other shoppers.I needed help and rode an electric cart to my car.At this point it had not been 20 minutes since putting the shoes on at home.I had the man that makes custom prescription orthotics look at the shoes comparing them to another pair of vionic.Shoes i have.He concluded the shoes were one size smaller than marked and this put the arch support on the orthotic footbed to be located behind my arch causing my ankle/foot to rotate/roll to the outside of my body.The right shoe on both pairs were distorted in a twist causing the sole to wobble front to back.I saw a general practitioner.

• Brand Name: VIONIC SHOES
• Type of Device: ORTHOSIS, CORRECTIVE SHOE
• Manufacturer (Section D): VIONIC
• MDR Report Key: 6947538
• MDR Text Key: 89451938
• Report Number: MW5072743
• Device Sequence Number: 1
• Product Code: KNP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/10/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 335ADLEY/ASR-1437
• Device Catalogue Number: OVC-A286564
• Device Lot Number: LC: 10-26-16
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability