AMIStem C Femoral Stems 01.18.157Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07630030804328), received between Jun 22, 2018 and Oct 30, 2018 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Packaging Problem” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 30, 2018Appropriate Device Problem Term/Code Not Available

  PATIENT CAME IN COMPLAINING OF PAIN, 1 YEAR AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THAT THE STEM HAD SUBSIDED. THE CAUSE OF THE SUBSIDENCE IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 8019257 ↗
• MalfunctionJun 22, 2018Packaging Problem; Packaging Problem

  THE PACKAGING WAS FOUND BROKEN, WITH PLASTIC DEBRIS ON THE PROSTHESIS. THE STEM WAS NOT USED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7629558 ↗

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