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HyProCure Size 06 HYP-06Recalls & reported problems

Graham Medical Technologies, L.L.C. · HyProCure Sinus Tarsi Implant Size 06. 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
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI M621HYP060), received between May 19, 2021 and May 19, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (2 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

  • Inadequacy of Device Shape and/or Size2
  • Insufficient Device Problem Information2
  • No Apparent Adverse Event2
  • Patient Device Interaction Problem2
  • Patient-Device Incompatibility2

Patient problems

  • Pain3
  • Discomfort2
  • Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
  • Insufficient Information1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 19, 2021Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem

    DEVICE MIGRATION.

    Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

    MAUDE report 11852030 ↗
  • InjuryMay 19, 2021No Apparent Adverse Event; No Apparent Adverse Event

    RANDOM OCCASIONAL PAIN AND DISCOMFORT, BUT IT'S STILL INFINITELY BETTER THAN BEFORE.

    Patient problems: Discomfort; Pain

    MAUDE report 11852015 ↗
  • InjuryMay 19, 2021Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem; Inadequacy of Device Shape and/or Size; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem

    MY IMPLANT WAS REMOVED TO PUT IN A BIGGER SIZE FOR BETTER CORRECTION. SLIGHT PAIN. DUE TO PANDEMIC, I HAVE NOT BEEN ABLE TO FOLLOW UP WITH MY DOCTOR SINCE I AM A HIGHER RISK.

    Patient problems: Discomfort; Pain

    MAUDE report 11852011 ↗
  • InjuryMay 19, 2021No Apparent Adverse Event; No Apparent Adverse Event

    PAIN WHEN LEANING A CERTAIN WAY. RIGHT NOW, ONLY ONE SIDE OF MY BODY IS ALIGNED, THE OTHER ISN'T. I NEED SURGERY ON MY OTHER FOOT SO I'LL BE ABLE TO WORK OUT AGAIN AND GAIN MY STRENGTH BACK.

    Patient problems: Pain

    MAUDE report 11851993 ↗

Other Screw, Fixation, Bone devices

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Sources and updates

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