AMIStem C Femoral Stems 01.18.155Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07630030804304), received between Feb 23, 2018 and Feb 26, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2026Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 6 YEARS AND 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO PAIN AS THE RESULT OF A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM TO A COMPETITOR STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24454895 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth; Adverse Event Without Identified Device or Use Problem; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 9 YEARS AND 6 MONTHS, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 21974795 ↗
• InjuryMay 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING MANUAL ROTATION WITHOUT SUFFICIENT TRACTION DURING REDUCTION, THE HEAD HIT THE RIM OF THE CUP AND CAUSED A FRACTURE IN THE CALCAR. THE LEG POSITIONER WAS USED, BUT WHEN THE FRACTURE OCCURRED, THE ROTATION WAS DONE MANUALLY. THE SURGERY WAS SUCCESSFULLY COMPLETED BY FIXING IT WITH A NESPRON CABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 16893407 ↗
• InjuryFeb 3, 2022Inadequacy of Device Shape and/or Size; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY DUE TO A LEG LENGTH DISCREPANCY. THE SURGEON REVISED THE STEM AND HEAD 2 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 13440314 ↗
• InjurySep 8, 2021Loose or Intermittent Connection

  2 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY 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 A COMPETITOR STEM AND HEAD, AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 12438435 ↗
• InjuryFeb 23, 2018Appropriate Device Problem Term/Code Not Available

  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: No Code Available

  MAUDE report 7291621 ↗
• InjuryFeb 23, 2018Loose or Intermittent Connection

  ON 24 JANUARY 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 7291619 ↗

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