HyProCure Size 07 HYP-07Recalls & reported problems
Graham Medical Technologies, L.L.C. · HyProCure Sinus Tarsi Implant Size 07. 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
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M621HYP070), received between May 19, 2021 and May 19, 2021 — classified as 6 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 Information6
- No Apparent Adverse Event2
- Patient Device Interaction Problem1
- Patient-Device Incompatibility1
Patient problems
- Discomfort3
- Insufficient Information3
- Pain2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryMay 19, 2021Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem
THE DEVICE HAS NOT CORRECTED THE PROBLEM.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 11852035 ↗InjuryMay 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
READJUSTING MY GAIT AFTER REMOVAL, AS I HAD A LIMP AND MISALIGNMENT IN MY LEFT HIP. (THE DEVICE LIMITED MOBILITY IN MY RIGHT FOOT AND ANKLE).
Patient problems: Discomfort
MAUDE report 11852033 ↗InjuryMay 19, 2021No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
IT APPEARS SOME OF THE HYPERPRONATION HAS RETURNED ON MY RIGHT FOOT (4 YEARS AFTER SURGERY) MAYBE I NEED A BIGGER SIZE.
Patient problems: Insufficient Information
MAUDE report 11852020 ↗InjuryMay 19, 2021No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE DEVICE DID NOT IMPROVE MY FOOT ALIGNMENT.
Patient problems: Insufficient Information
MAUDE report 11852017 ↗InjuryMay 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
CONTINUED MILD PAIN AT SITE OF IMPLANT (NOT DAILY) IN THE MORNINGS, AFTER WALKING SEVERAL BLOCKS, WEARING RIGID SHOES OR SHOES WITH A HEEL OR DURING INCLEMENT WEATHER, ALL MANAGEABLE WITH PRN TYLENOL.
Patient problems: Discomfort; Pain
MAUDE report 11852009 ↗InjuryMay 19, 2021Insufficient Device Problem Information; Insufficient Device Problem Information
OCCASIONAL CONTINUED MORTON/S NEUROMA PAIN WHEN I RAINS AND FREQUENT MILD PLANTAR/LATERAL FIFTH METATARSAL PAIN WHEN WALKING, ALL MANAGEABLE WITH PRN TYLENOL.
Patient problems: Discomfort; Pain
MAUDE report 11852008 ↗
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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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