AMIStem C Femoral Stems 01.18.100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030803789), received between May 25, 2022 and Oct 20, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 20, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AFTER 5 MONTHS, THE PATIENT CAME IN DUE TO AN INFECTION, AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HEAD, LINER, AND STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 23334293 ↗
• InjuryMar 7, 2023Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 10 MONTHS AFTER THE PRIMARY SURGERY, STEM AND HEAD WERE REVISED DUE TO STEM MOBILIZATION. QUADRA P IMPLANTED.

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

  MAUDE report 16494449 ↗
• InjuryMay 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2019. THE REVISION SURGERY DUE TO INFECTION WAS PERFORMED ON (B)(6) 2019. THE SURGEON REVISED SUCCESSFULLY THE STEM AND HEAD. THE SURGEON NOTICED A RE-INFECTION WHEN THE PATIENT CAME TO THE HOSPITAL FOR A FOLLOW-UP ON (B)(6) 2022. THE REVISION SURGERY WAS PERFORMED SUCCESSFULLY ON (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 14496130 ↗

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