AMIStem C Femoral Stems 01.18.154Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630030804298), received between Dec 29, 2017 and Mar 15, 2023 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K103189); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  POST-OP CONTROL X-RAY REVEALED A FEMORAL BONE FRACTURE. AT 5 DAYS AFTER THE PRIMARY, THE SURGEON REVISED STEM, HEAD AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 16544240 ↗
• InjuryMar 24, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS ENTEROCOCCUS. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11561534 ↗
• InjuryApr 15, 2020Adverse Event Without Identified Device or Use Problem

  1 MONTH AFTER PRIMARY SURGERY, REVISION SURGERY FOR INFECTION. THE STEM, THE HEAD AND THE DOUBLE MOBILE LINER REVISED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9961666 ↗
• InjuryJan 31, 2019Appropriate Device Problem Term/Code Not Available

  ABOUT 6 YEARS AND A HALF AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR AN INFECTION. ALL HARDWARE REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 8292561 ↗
• InjuryDec 29, 2017Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR A POTTED STEM 3 YEARS AFTER PRIMARY [REPORT (B)(4)]. THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR LATER: THE STEM HAD SUBSIDED. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7153837 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K103189. 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