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AMIStem C Femoral Stems 01.18.101Recalls & reported problems

Medacta International SA · AMIStem C Cemented Stem Lateralized Size 1 · Class 2 · Implant

All models of AMIStem C Femoral Stems (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07630030803796), received between Mar 1, 2019 and Jun 9, 2023 — classified as 2 injuries, 1 malfunction.

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

Device problems

  • Appropriate Device Problem Term/Code Not Available1
  • Break1
  • Tear, Rip or Hole in Device Packaging1

Patient problems

  • Bone Fracture(s)1
  • No Code Available1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 9, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    CALCAR FRACTURE OCCURRED DURING SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED BY FIXING THE BONE FRACTURE. THE BONE QUALITY IS WEAK.

    Patient problems: Bone Fracture(s)

    MAUDE report 17097685 ↗
  • InjuryJul 31, 2019Break

    THE SURGEON DISCOVERED DURING THE SURGERY, THE INNER BLISTER OF AMISTEM-C WAS BROKEN. THE SURGERY WAS COMPLETED WITH THE BACKUP IMPLANT.

    Patient problems: No Code Available

    MAUDE report 8845661 ↗
  • MalfunctionMar 1, 2019Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

    DURING SURGERY, THE OUTER BLISTER WAS CHECKED AND NO HOLES/ DEFECT WERE FOUND, WHILE THE SECOND BLISTER WAS FOUND BROKEN AND A PART OF THE STEM WAS OUT OF THE BLISTER. THE SURGERY WAS COMPLETED WITH ANOTHER STEM.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8381780 ↗

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

Other Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices

All Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page