AMIStem-P 01.18.417Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040720168), received between Apr 30, 2019 and Dec 20, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A BONE BROKEN FEMUR DISTAL TO THE MEDACTA STEM. THE PATIENT DID NOT REPORT ANY TRAUMA. THE SURGEON CABLED THE FRACTURE AND REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 23858468 ↗
• InjuryMay 31, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY HIP SURGERY ON (B)(6) 2021. ON THE (B)(6) 2021, THE PATIENT CAME WITH SIGNS OF INFECTION AND A WASHOUT WAS PERFORMED. ON THE (B)(6) 2023, THE PATIENT CAME DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS STAPHYLOCOCCUS. ALL THE IMPLANTS HAVE BEEN REVISED AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bacterial Infection

  MAUDE report 17029867 ↗
• InjuryOct 13, 2020Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN DUE TO A SUBSIDED STEM AFTER 1 YEAR AND 5 MONTHS FROM THE PRIMARY SURGERY. THE SURGEON REVISED THE STEM, HEAD, AND LINER. DURING THE PRIMARY HIP SURGERY, WHILE THE SURGEON WAS INSERTING THE STEM, THE PATIENT'S GREATER TROCHANTER FRACTURED. THE SURGEON CABLED THE FRACTURE.

  Patient problems: Pain

  MAUDE report 10668668 ↗
• InjuryApr 30, 2019Adverse Event Without Identified Device or Use Problem

  DURING THE PRIMARY HIP SURGERY AND WHILE INSERTING THE STEM, THE PATIENT'S GREATER TROCHANTER FRACTURED. THE SURGEON CABLED THE FRACTURE AND THERE WAS A 5-MINUTE DELAY IN THE CASE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 8564991 ↗