It was reported by the end users spouse that the left back wheel was loose and the end user lost her balance resulting in a fall that caused a fracture to the right humorous and required surgical intervention.According to the spouse, his wife was walking outside and when she was just 3 steps outside the door he saw her falling into a brick wall.According to the spouse an ambulance was called and transported the end user to the hospital.The end user underwent a full assessment with x-rays and computed tomography (ct) scan and was found to have a fractured right humorous.The end user had surgery on (b)(6) 2021 to repair the injury and is being transferred to a rehab facility for strength training.The spouse reported that he returned the device to the retail store for a replacement and the device is not available to return for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
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