AMIStem C Femoral Stems 01.18.156Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030804311), received between Sep 29, 2017 and Feb 28, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 28, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT 4 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 18795925 ↗
• InjuryDec 19, 2023Migration or Expulsion of Device; Migration or Expulsion of Device

  REVISION SURGERY FOR CEMENTED STEM SUBSIDENCE AT ABOUT 1 MONTH FROM THE PRIMARY. DURING THE SURGERY, A FEMORAL BONE FRACTURE WAS FOUND AND REPAIRED WITH CABLE AND A PLATE. THE STEM AND HEAD HAVE BEEN REVISED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 18356434 ↗
• InjuryFeb 23, 2018Loose or Intermittent Connection

  ON (B)(6) 2018 THE SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON THAT A REVISION SURGERY WAS PERFORMED. AT THIS TIME WE DO NOT KNOW IF THE REASON OF THE REVISION SURGERY IS BONE FRACTURE OR STEM LOOSENING.

  Patient problems: Bone Fracture(s)

  MAUDE report 7291625 ↗
• InjurySep 29, 2017Fracture

  DURING SURGERY, GREATER TROCHANTER AND FEMORAL BONE WERE FRACTURED. GREATER TROCHANTER FRACTURE WAS CONFIRMED AFTER EXTENDING THE FEMUR. FEMORAL BONE FRACTURE (BELOW THE STEM) WAS CONFIRMED AFTER IMPLANTATION OF THE STEM. DUE TO THIS EVENT, THE SURGERY WAS PROLONGED ABOUT 4 HOURS. IT WAS NOT CLEAR, BUT GREATER TROCHANTER FRACTURE MIGHT BE OCCURED DURING EXTERNAL ROTATION AFTER FEMORAL HEAD RESECTION. FEMORAL BONE FRACTURE MIGHT BE OCCURED WHILE RASPING OR INSERTING THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 6903980 ↗

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