AMIStem H Collared Femoral Stems 01.18.241Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030804663), received between Feb 12, 2019 and Nov 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 YEARS AND 10-MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER TO MEDACTA COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23579772 ↗
• InjuryFeb 14, 2020Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY PERFORMED 2 YEARS AFTER THE PRIMARY DUE TO A LACK OF OSSEOINTEGRATION. THE STEM AND THE HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9710935 ↗
• InjuryFeb 12, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 2 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED ALL THE PATIENT HARDWARE FOR INFECTION. ANTIBIOTIC SPACER INSERTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8331034 ↗