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AMIStem H Collared Femoral Stems 01.18.247Recalls & reported problems

Medacta International SA · AMIStem Collared HA coated stem Size 7 LAT · Class 2 · Implant

All models of AMIStem H Collared Femoral Stems (17)

Data updated Oct 18, 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 07630030804724), received between May 28, 2019 and May 28, 2019 — classified as 1 injury.

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

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Inflammation1

Recent adverse event reports

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

  • InjuryMay 28, 2019Adverse Event Without Identified Device or Use Problem

    REVISION SURGERY PERFORMED 6 YEARS AND TWO MONTHS AFTER PRIMARY SURGERY DUE TO FEMORAL INFLAMMATION. STEM AND HEAD HAVE BEEN REVISED.

    Patient problems: Inflammation

    MAUDE report 8645813 ↗

Other Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented devices →

Sources and updates

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