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SIZER FOR STEM DIAMETER 13 210874Recalls & reported problems

Fournitures Hospitalieres Industrie · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03661489108747), received between Oct 19, 2018 and Oct 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionOct 19, 2018Material Fragmentation; Material Fragmentation

    DURING THE INSERTION OF A HIP PROSTHESIS, THE TIP OF THE ESOP FEMORAL SIZER BROKE IN THE FEMUR.

    Patient problems: No Information

    MAUDE report 7984875 ↗

Other Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate devices

All Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.