HyProCure Size 05 HYP-05Recalls & reported problems
Graham Medical Technologies, L.L.C. · HyProCure Sinus Tarsi Implant Size 05. Indications: HyProCure is a talotarsal stabilization device used in the treatment of talotarsal dislocation and resulting sequela. The implant is designed to stabilize the talus on the tarsal mechanism to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus on the tarsal mechanism, while allowing normal talotarsal joint motion. · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI M621HYP050), received between May 19, 2021 and May 19, 2021 — classified as 7 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information5
- No Apparent Adverse Event4
Patient problems
- Discomfort6
- Pain5
- Insufficient Information2
- Swelling/ Edema1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
InjuryMay 19, 2021No Apparent Adverse Event; No Apparent Adverse Event
I FELT THAT MY IMPROVEMENT, WHILE SIGNFICANT WHEN COMPARED TO PRE-HYPROCURE SURGERY, HAD PLATEAUED. PODIATRIST RECOMMENDED A REVISION SURGERY WITH A BIGGER SIZE IMPLANT.
Patient problems: Insufficient Information
MAUDE report 11852022 ↗InjuryMay 19, 2021No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
PAIN AND SWELLING WITH CUTTING ACTIVITIES.
Patient problems: Discomfort; Pain; Swelling/ Edema
MAUDE report 11852019 ↗InjuryMay 19, 2021No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
I OCCASIONALLY GET NUMBNESS IN MY LAST TWO TOES. THE NUMBNESS SEEMS TO BE A RESULT OF A CALLUS THAT FORMS ON THE OUTSIDE BALL OF MY FEET WHEN I SPEND MORE TIME STANDING AND WALKING THAN MY USUAL AMOUNT. WHEN THE CALLUS IS LESS PROMINENT, THE NUMBNESS GOES AWAY.
Patient problems: Discomfort; Insufficient Information
MAUDE report 11852016 ↗InjuryMay 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
I HAVE LASTING PAIN IF I SIT/SLEEP WITH MY ANKLE IN A TURNED INWARD POSITION. THE PAIN IS ABOVE THE INCISION AND ABOUT THE SIZE OF A QUARTER. WHEN I TRIED TO WEAR HIGH HEELS, I HAD MODERATE PAIN AND MY ANKLES FELT VERY UNSTABLE.
Patient problems: Discomfort; Pain
MAUDE report 11852012 ↗InjuryMay 19, 2021No Apparent Adverse Event; No Apparent Adverse Event
RIGHT FOOT - DISCOMFORT WHEN WALKING, AND ESPECIALLY RUNNING, ON BUMPY, UNEVEN SURFACES.
Patient problems: Discomfort; Pain
MAUDE report 11852002 ↗InjuryMay 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
MY RIGHT FOOT IS VERY WEAK. I CANNOT STAND FOR A LONG TIME BECAUSE MY RIGHT ANKLE IS PAINFUL. DUE TO THE PANDEMIC, I HAVE NOT BEEN TO THE DR. OFFICE. LIFE IS CHAOTIC RIGHT NOW BEING HOME WITH THREE CHILDREN. I HAVE TO FOCUS ON MY FAMILY.
Patient problems: Discomfort; Pain
MAUDE report 11851999 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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