AMIStem-H Proximal Coating Femoral Stems 01.18.176Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030804410), received between Aug 30, 2017 and Oct 30, 2019 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Slipped” (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.

• InjuryOct 30, 2019Device Slipped

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A SUBSIDED STEM. THE SURGEON PERFORMED AN EXTENDED TROCHANTERIC OSTEOTOMY AND REVISED THE STEM AND LINER ALMOST 2 YEARS AND 2 MONTHS AFTER PREVIOUS SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9254773 ↗
• InjuryFeb 9, 2018Loose or Intermittent Connection

  THE PATIENT CAME IN COMPLAINING OF PAIN 2 MONTHS AFTER PRIMARY. THE STEM HAD SUBSIDED. THE SURGEON BELIEVES THE CAUSE OF THE SUBSIDENCE IS DUE TO POOR BONE QUALITY. STEM AND HEAD REVISED WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7259387 ↗
• InjuryAug 30, 2017Fracture

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE PATIENT FRACTURED THE FEMUR BONE. THE CAUSE OF THE FRACTURE IS UNKNOWN. THE SURGEON CABLED THE FEMUR AND REVISED THE HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. X-RAYS ARE AVAILABLE. EXPLANTS ARE NOT AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6829713 ↗