AMIStem-H Proximal Coating Femoral Stems 01.18.173Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030804380), received between Feb 22, 2019 and Dec 23, 2021 — classified as 7 injuries.

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.

• InjuryDec 23, 2021Osseointegration Problem; Osseointegration Problem

  AT 3 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUE TO STEM MOBILIZATION.

  Patient problems: Joint Laxity

  MAUDE report 13073517 ↗
• InjurySep 3, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  ABOUT 1 YEAR AFTER PRIMARY SURGERY THE PATIENT STEM WAS REVISED FOR LOOSENING. THIS IS THE THIRD REVISION REPORTED ON THIS PATIENT FOR DIFFERENT REASONS SINCE THE PRIMARY SURGERY. THE CORRECT DATE AND LOCATION FOR THE FIRST REVISION IS NOT KNOWN.

  Patient problems: Joint Disorder

  MAUDE report 10486940 ↗
• InjuryJan 8, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A POTTED STEM. THE SURGEON REVISED THE STEM AND HEAD 1 YEAR AND 7 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9563215 ↗
• InjuryNov 6, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 YEAR AND 4 MONTHS AFTER THE PRIMARY DUE TO INFECTION AND OBSERVED SUBCUTAN SWELLING. THE KIND OF PATHOGEN IS UNKNOWN. ALL IMPLANTS HAVE BEEN REMOVED, PATHOGEN IS BEING ANALYZED. NO REIMPLANTATION AT THE MOMENT.

  Patient problems: Unspecified Infection

  MAUDE report 9284521 ↗
• InjurySep 27, 2019Inadequacy of Device Shape and/or Size

  REVISION SURGERY, AFTER 10 MONTHS FROM THE PRIMARY DUE TO PAIN. THE PATIENT CAME IN COMPLAINING OF PAIN AND THE CAUSE OF THE PAIN WAS AN UNDERSIZED STEM. THE SURGEON REVISED THE HEAD AND STEM. WHEN THE SURGEON WAS REVISING THE STEM, IT WAS OBSERVED THAT THE STEM HAD IN GROWTH WHEN IT WAS EXPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 9128783 ↗
• InjuryAug 9, 2019Appropriate Device Problem Term/Code Not Available

  THE PATIENT FELT PAIN AND HA AND DIFFICULTIES TO WALK, THE CAUSES OF THIS CONDITION ARE UNKNOWN. THE SURGEON REVISED THE STEM AND THE HEAD 1 YEAR AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY. WE WERE INFORMED ABOUT THE EVENT ON (B)(6) THE REVISION SURGERY WAS PERFORMED ON (B)(6).

  Patient problems: Pain

  MAUDE report 8878380 ↗
• InjuryFeb 22, 2019Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO STEM LOOSENING. DATE OF PRIMARY SURGERY AND DETAILS ABOUT THE BALL HEAD ARE UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8361561 ↗