AMIStem-P Collared 01.18.440Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630040720298), received between Dec 19, 2023 and Sep 9, 2026 — classified as 3 injuries.

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

• InjurySep 9, 2026Osseointegration Problem

  At about 7 months from the primary, the patient came in presenting pain and instability 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 Flat PE HC liner D 36/E to a same size liner. The surgery was completed successfully.

  Patient problems: Aseptic loosening; Implant Pain; Inadequate Osseointegration

  MAUDE report 50692306 ↗
• InjuryJul 6, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 WEEK FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A FRACTURED FEMUR AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA.THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR DEVICES AND REPLACED THE DOUBLE MOBILITY LINER WITH A LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 25714736 ↗
• InjuryDec 19, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  WHEN PREPARING THE BONE WITH THE AMISTEM BROACHES (SAME BROACHES FOR AMISTEM-H) THE SIZE 0 BROACH WAS REACHED. IT SAT TIGHT WITHIN THE ENVELOPE OF THE FEMUR. THE MEDIAL ASPECT OF THE BROACH WAS ON THE CORTICAL BONE OF THE MEDIAL CALCAR AS THE PLANNING INDICATED. TRIAL REDUCTION WAS PERFORMED AND THE DEFINITIVE STEM WAS SELECTED. ON IMPLANTING THE DEFINITIVE STEM, SIZE 0 LATERAL AMISTEM-P COLLARED, THE STEM SAT UP APPROXIMATELY 5MM FROM THE TRIAL COMPONENT POSITION. THE SURGEON CONTINUED TO IMPACT THE STEM WHEN HE NOTICED A FRACTURE ON THE ANTERO MEDIAL WALL OF THE CALCAR. A CABLE WAS USED TO REDUCE THE RISK OF THE FRACTURE PROPAGATING FURTHER. THE STEM WAS NOT REPLACED OR REMOVED.

  Patient problems: Bone Fracture(s)

  MAUDE report 18356433 ↗