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HIP Instruments 01.18.10.412Recalls & reported problems

Medacta International SA · AMIStem Broach v2 #2 · Class 1

All models of Hip Instruments (48)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040745505), received between Jul 20, 2020 and Jul 20, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (1 report).

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 16, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryJul 20, 2020Fracture

    AFTER THE FEMUR BROACHING FOR AMISTEM-P IMPLANTATION, THE SURGEON DISCOVERED A FEMORAL FRACTURE IN THE X-RAY FROM THE DISTAL LATERAL SIDE TO THE MEDIAL PART OF THE LESSER TROCHANTER. THE SURGEON FIXED THE FRACTURE WITH THE PLATE, THE CABLE AND THE SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Patient problems: Bone Fracture(s)

    MAUDE report 10294919 ↗

Other Orthopedic Manual Surgical Instrument devices

All Orthopedic Manual Surgical Instrument devices →

Sources and updates

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