HyProCure II Sinus Tarsi Stent Size 11 HYP II-11Recalls & reported problems
Graham Medical Technologies, L.L.C. · HyProCure II Sinus Tarsi Implant Size 11. Indications: HyProCure II (HYP II and HYP IIs) is an implant stabilization device used in the treatment of hyperpronating instability of the hindfoot. The implant is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, 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 M621HYPII110), received between Apr 27, 2022 and Apr 26, 2023 — classified as 6 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-Device Incompatibility2
- Migration1
Patient problems
- Insufficient Information5
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- No Clinical Signs, Symptoms or Conditions3
- Ambulation or Postural Difficulties1
- Discomfort1
- Loss of Range of Motion1
- Pain1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryApr 26, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE PATIENT NOTED "SOMEWHAT SATISFIED" HAS ARCH CRAMPS AND PAIN IN ANKLE.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16814930 ↗InjuryApr 26, 2023Patient-Device Incompatibility; Insufficient Device Problem Information; Patient-Device Incompatibility; Insufficient Device Problem Information
THE PATIENT NOTED "VERY DISSATISFIED" IMPLANT FAILED NOT ADDING ANY ARCH TO MY FOOT.
Patient problems: Discomfort; Insufficient Information; No Clinical Signs, Symptoms or Conditions; Pain
MAUDE report 16814929 ↗InjuryApr 26, 2023Patient-Device Incompatibility; No Apparent Adverse Event; Insufficient Device Problem Information; Patient-Device Incompatibility; No Apparent Adverse Event; Insufficient Device Problem Information
THE PATIENT NOTED THIS DEVICE LIMITED MOBILITY IN MY RIGHT FOOT AND ANKLE CONSIDERABLY.
Patient problems: Ambulation or Postural Difficulties; Insufficient Information; Loss of Range of Motion; No Clinical Signs, Symptoms or Conditions
MAUDE report 16814927 ↗InjuryApr 26, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE PATIENT NOTED THIS DEVICE DID NOT IMPROVE MY ARCH. MY FOOT IS STILL FLAT AND WALKING IS DIFFICULT AND GETTING SHOES IS DIFFICULT. I ALSO HAVE SEVERE NEUROPATHY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16814926 ↗InjuryApr 26, 2023No Apparent Adverse Event; Insufficient Device Problem Information; No Apparent Adverse Event; Insufficient Device Problem Information
THE PATIENT NOTED THIS DEVICE DID NOT IMPROVE MY ARCH. MY FOOT IS STILL FLAT AND WALKING IS DIFFICULT AND GETTING SHOES IS DIFFICULT. I ALSO HAVE SEVERE NEUROPATHY.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information
MAUDE report 16814925 ↗InjuryApr 27, 2022Migration; Migration
THE PATIENT DESCRIBED BEING 'VERY SATISFIED' WITH THE DEVICE. AT 2 WEEKS POST-OP APPOINTMENT, THE IMPLANT HAD A SLIGHT LATERAL DEVIATION AND SURGICAL REVISION WAS SCHEDULED.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 14222002 ↗
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- HEALIX PEEK ORTHOCORD 222205Medos International Sàrl · Screw, fixation, bone186 reports
- PRECICE® Bone Transport System STP3.5-400Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-225Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-350Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
- PRECICE® Bone Transport System STP3.5-300Nuvasive Specialized Orthopedics, Inc. · Screw, Fixation, Bone3 recalls0 reports
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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