PROPRIO FOOT
Received Oct 8, 2021 · Event occurred Apr 1, 2021
Report MW5104535 · MDR key 12615962
Device
Generic name
Component, External, Limb, Ankle/foot
Model number
PSX01627RProduct problems
- Patient-Device Incompatibility
Patient
52 YR
- Fall
- Fatigue
- Discomfort
- Arthralgia
- Ambulation or Postural Difficulties
- Fall
- Fatigue
- Discomfort
- Arthralgia
- Ambulation or Postural Difficulties
Narrative
Description of Event or Problem
I WANTED TO LET YOU KNOW THAT I GAVE THE PROPRIO FOOT A GOOD GO OF IT, BUT ENDED UP DECIDING THAT IT WAS A VERY BAD FIT FOR ME. I AM NOT SURE HOW I, AS A PROSTHETIC USER, MIGHT BE OUTPERFORMING THE AI AND PREDICTIVE ANALYSIS OF THE SOFTWARE, BUT I SURE SEEM TO BE. BELOW ARE A COUPLE OF THE CHIEF ISSUES THAT I SEEM TO HAVE HAD WITH THE FOOT. IT DOES PREDICT STEPS, SUCH AS GOING UP INCLINES, REGULAR STEPS AND STAIRS, ETC. I BELIEVE IT DOES THIS WELL. WHERE I HAD SEVERAL ISSUES WAS IN IT PREDICTING POORLY WHEN THOSE STEPS WERE GOING TO STOP. I THINK THIS MAY BE A REFLECTION OF MY ACTIVITY LEVEL AS I WALK/RUN QUICKLY AND THE LACK OF OR WRONG RESISTANCE ON THE HEAL TO TOE ACTION WHEN COMING TO THE END OF THOSE STEPS CAUSED A COUPLE OF FALLS, AND A FAIR NUMBER OF STUMBLES. AFTER A COUPLE OF DAYS OF OUR PREVIOUS EXCHANGE, I DID HAVE THAT INTERMITTENT ISSUE OF THE TOE / RESISTANCE SIMPLY NOT BEING THERE IN NORMAL STRIDE. AGAIN, I AM THINKING THIS IS DUE TO ME BE A FAIRLY FAST WALKER. NOT SURE IF SPEED, OR PERHAPS AN IRREGULAR GAIT WHEN GOING FAST WAS CAUSING THIS. I STUMBLE, BUT NO MORE REAL FALLS. I AM ACTUALLY A PRETTY BALANCED WALKER, HOWEVER THE PHYSICS OF MOMENTUM WERE NOT ON MY SIDE WHEN MOVING QUICKLY AND UNEXPECTEDLY ENCOUNTERING THIS. LACK OF KINETIC RETURN. AGAIN, HIGH ACTIVITY USER, WHO LIKES TO WALK, WORK OUT AND RUN (AS I CAN). THE LACK OF ANY EFFECTIVE KINETIC RETURN TO MY RIGHT FOOT WAS CAUSING: FATIGUE TOO SOON; KNEE ACHE; LEFT HIP DISCOMFORT. ALL DUE TO COMPENSATION OF THOSE JOINTS AND MUSCLES TO TRY AND MAKE UP FOR THAT LOSS OF PASSIVE KINETIC RETURN TO THE RIGHT FOOT (PROPRIO); FAIR TO NOTE THAT I WAS COMING OUT OF RUSH FEET KNOWN FOR THEIR COMPLETELY PASSIVE NATURE BUT HIGH KINETIC RETURN. DUE TO ALL OF THESE FACTORS I HAVE CHOSEN TO DISCONTINUE THE USE OF MY PROPRIO (I ACTUALLY DID THAT BACK IN APRIL). I HAVE RECENTLY LISTED THE FOOT FOR SALE, AND AM HOPING IT MAY FIT ANOTHER AMPUTEE'S NEEDS MUCH BETTER. I KNOW I AM NOT A CLINICIAN BY ANY STRETCH OF THE IMAGINATION, BUT MY RECOMMENDATION IS TO KEEP THE DEVELOPMENT GOING! IT IS GREAT TO SEE STRIDES IN THIS INDUSTRY. AS FOR THE PROPRIO ITSELF, I THINK IT MAY BE AWESOME FOR A LOW COMPLEXITY/IMPACT USER, BUT SHOULD BE AVOIDED AT ALL COSTS BY HIGHER IMPACT AND ACTIVITY USERS. IF MY EXPERIENCE IS ANY GUIDE, IT COULD REPRESENT SOME LEGAL LIABILITY TO 'OSSUR' IN THE LONG RUN, AND AS MUCH AS I RESPECT YOUR COMPANY, I WOULD ABSOLUTELY HATE TO SEE THAT. FDA SAFETY REPORT ID# (B)(4).