AMIStem H Femoral Stems 01.18.138Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030804144), received between Sep 29, 2022 and Sep 9, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (2 reports).

1 other recall cover devices cleared under the same FDA submission (K093944, K250450); they may or may not involve this specific model.

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.

• InjurySep 9, 2026Osseointegration Problem

  At about 11 years and 8 months from the primary, the patient came in presenting pain due to a loose stem and the cause is unknown. The surgeon revised the Medacta stem and head to a competitor stem and head, and revised the Versafitcup DM Liner HC 54/28 to a Double Mobility HC Liner D 28/DMG. The surgery was completed successfully.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 50692311 ↗
• InjuryMar 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 6 YEARS AND 2 MONTHS FROM PRIMARY, THE PATIENT CAME IN REPORTING THIGH PAIN AND THE CAUSE 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: Implant Pain

  MAUDE report 21643590 ↗
• InjurySep 29, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. AT 7 YEARS AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE STEM, HEAD, AND LINER WITH COMPETITOR COMPONENTS, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 15509010 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093944, K250450. One submission often covers many models, so check the product and lot details in each record.

• Z-0791-2013 · Dec 17, 2012 · Terminated
  Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur