C-STEM 1570-04-110Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295059646), received between Oct 6, 2022 and Oct 31, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (1 report).

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 16, 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 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION SURGERY, HEMI HIP PROTHESIS WITH CATH CART HEAD. THERE WAS EXTREME BONE LOSS FEMORAL AND ACETABULAR SIDE, SIGNS OF METALLOSIS. PATIENT CONSEQUENCES INCLUDE POSSIBLE CAUSE OF DESTRUCTION, DISLOCATION AND REVISION. ACTION TAKEN TO RESOLVE THE ISSUE INCLUDED EXTRACTION OF THE PROSTHESIS. DEFINITE GIRDLESTONE DUE TO RECONSTRUCTABLE BONE DEFECT FEMORAL AND ACETABULAR SIDE.

  Patient problems: Bone Notching; Foreign Body Reaction

  MAUDE report 23434917 ↗
• MalfunctionOct 6, 2022Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping; Tear, Rip or Hole in Device Packaging; Device Contaminated During Manufacture or Shipping

  IMPLANT BOX GOT BEAT UP AND BECAME COMPROMISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15552648 ↗