VARI-FLEX
Received Feb 1, 2021 · Event occurred Jul 8, 2017
Report 3003764610-2021-00001 · MDR key 11257219
Product problems
- Break
Patient
Not reported
- Fall
- Depression
- Irritability
- Fall
- Depression
- Irritability
Narrative
Additional Manufacturer Narrative
ON (B)(6) 2017 THE PATIENT VISITED THE HANGER CLINIC TO GET A REPLACEMENT PROSTHESIS DUE TO A BROKEN PROXIMAL PYRAMID ON THE VARI-FLEX FOOT. THE PATIENT STATED THAT HE FELL ON (B)(6) WHILE TAKING OUT THE TRASH BUT WAS NOT INJURED. THE CLINIC CHANGED OUT TO AN OLD FOOT AND ORDERED A NEW ONE. THE BROKEN FOOT WAS SENT BACK TO THE MANUFACTURER FOR ANALYSIS. THE PATIENT VISITED THE CLINIC AGAIN ON (B)(6) TO GET THE NEW FOOT FITTED. THE PATIENT DID NOT MENTION ANY INJURIES IN THE SECOND VISIT. JULY 3RD 2019 THE PATIENT FILED A COMPLAINT ASKING FOR DAMAGES FROM THE MANUFACTURER DUE TO THE INCIDENT IN 2017. MID JANUARY 2021 THE MANUFACTURER RECEIVED INFORMATION THAT THE PATIENT CLAIMS HE HIT HIS HEAD IN THE FALL IN 2017 AND UNDERLYING MEDICAL CONDITIONS HAD WORSENED DUE TO THAT.
Description of Event or Problem
INITIAL EVENT WAS IN 2017 WHEN THE PATIENT'S PROSTHETIC FOOT BROKE BUT NO INJURIES WERE REPORTED RELATED TO THIS INCIDENT. PATIENT NOW CLAIMS HE FELL AND HIT HIS HEAD WHEN THE FOOT BROKE IN 2017 CAUSING SYMPTOMS FROM PREVIOUS UNRELATED ACCIDENT TO WORSEN SUCH AS LOW ENERGY AND MOTIVATION, IRRITABILITY, AND DEPRESSION .