AMIStem C Femoral Stems 01.18.103Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630030803819), received between Feb 23, 2018 and Jun 9, 2026 — classified as 4 injuries.

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

• InjuryJun 9, 2026Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT, AND REVISED ALL COMPONENT SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 25442543 ↗
• InjuryNov 15, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 8 YEARS AND 3 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF STEM LOOSENING. STEM, BALL HEAD AND LINER HAVE BEEN REVISED SUCCESSFULLY. NOTE: THE SURGEON COMMENTED THAT A POSSIBLE CAUSE OF THE INSUFFICIENT INTEGRATION IN THE CEMENT WAS THE HIGH ACTIVITY OF THE PATIENT SINCE EARLY.

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

  MAUDE report 18139034 ↗
• InjuryDec 10, 2020Break

  THE PATIENT HAD REVISION SURGERY ON (B)(6) 2020. HOWEVER, 2 MONTHS AFTER PREVIOUS SURGERY, THE FEMUR BROKE PROBABLY DUE TO TRAUMA AND DUE TO THE THINNER BONE WALLS. THEREFORE THE SURGEON REVISED THE PATIENT AGAIN AND REMOVED OUR STEM AND HEAD IMPLANTING COMPETITOR'S DEVICES.

  Patient problems: Bone Fracture(s)

  MAUDE report 10983869 ↗
• 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 WILL BE 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 7291620 ↗

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