AMIStem H Femoral Stems 01.18.098Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030803765), received between Nov 15, 2017 and Nov 28, 2025 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2025Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEAM AND HEAD. HE ALSO REVISED THE MEDACTA CUP AND LINER TO A MEDACTA CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Inadequate Osseointegration

  MAUDE report 23669497 ↗
• InjuryApr 22, 2021Osseointegration Problem; Unintended Movement

  REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION 4 YEARS AFTER THE PRIMARY. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD.

  Patient problems: Inadequate Osseointegration

  MAUDE report 11706279 ↗
• InjuryOct 31, 2019Loose or Intermittent Connection; Microbial Contamination of Device

  ABOUT 3 YEARS AND 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR STEM LOOSENING. ALL HARDWARE REVISED SUCCESSFULLY. BETWEEN PRIMARY AND THIS SURGERY THE PATIENT HAD ANOTHER REVISION FOR INFECTION ON THE (B)(6) 2017 WHERE ALL ACETABULAR COMPONENTS AND THE CERAMIC HEAD WERE REVISED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9260470 ↗
• InjuryOct 18, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED 5 YEARS AFTER THE PRIMARY SURGERY DUE TO FEMORAL LOOSENING.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9206480 ↗
• InjuryApr 20, 2018Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO PAIN. THE STEM WAS FIXED DISTALLY AND MOBILIZED PROXIMALLY (STEM POTTED) AFTER ABOUT 4 YEARS FROM PRIMARY.

  Patient problems: Joint Disorder

  MAUDE report 7446633 ↗
• MalfunctionApr 19, 2018Packaging Problem; Packaging Problem

  WHEN THE STEM WAS OPENED IT WAS NOTICED THAT THE HARD PLASTIC WAS DAMAGED. THE EXTERNAL BOX WAS INTACT. THE SURGEON USED A SECONDARY STEM TO COMPLETE THE SURGERY. THERE WAS NO DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7442490 ↗
• InjuryNov 15, 2017Device Operates Differently Than Expected

  THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THAT THE STEM HAS SUBSIDED. THE CAUSE IS UNKNOWN. THE SURGEON SWAPPED THE HEAD. THE STEM WAS WELL FIXED AT THIS POINT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7032796 ↗