AMIStem H Collared Femoral Stems 01.18.244Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030804694), received between Jun 13, 2019 and Feb 12, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2026Osseointegration Problem

  AT ABOUT 6 YEARS AND 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE STEM, THE HEAD AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 24321116 ↗
• InjuryDec 20, 2023Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 7 YEARS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18365277 ↗
• InjuryNov 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PERIPROSTHETIC BONE FRACTURE DISCOVERED BY 1 DAY POST-OP X-RAYS. THE FRACTURE WILL BE MANAGED CONSERVATIVELY, WITH NO REVISION SURGERY PLANNED AT THIS STAGE. THE SURGEON SUSPECTS THE FRACTURE OCCURRED DURING THE FINAL STEM IMPLANTATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 15779285 ↗
• InjuryDec 5, 2019Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN COMPLAINING OF INSTABILITY WHICH WAS CAUSED FROM A LOOSE STEM. THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD, AND LINER ALMOST 4 YEARS AND 8 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9416216 ↗
• InjuryJun 13, 2019Loose or Intermittent Connection

  ON MAY 14 WE WERE INFORMED ABOUT THE COMPLAINT. THE REVISION SURGERY WAS PERFORMED ON MAY 15. THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8695291 ↗