Skip to content

Hip Instruments 01.10.10.003Recalls & reported problems

Medacta International SA · Screwed stem extractor m8 · Class 1

All models of Hip Instruments (48)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 07630040739337), received between Apr 25, 2023 and Apr 25, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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

Device problems

  • Fracture1

Patient problems

  • Insufficient Information1

Recent adverse event reports

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

  • MalfunctionApr 25, 2023Fracture; Fracture

    WHEN THE SURGEON WAS TRYING TO EXTRACT THE STEM WITH THE STEM EXTRACTOR, THE SURGEON THREADED THE EXTRACTOR AND STARTED HAMMERING IT OUT AND THE TIP BROKE AND REMAINED IN THE STEM. THE SURGEON ATTEMPTED TO REMOVE THE INSTRUMENT TIP FOR 2 HOURS IN VARIOUS WAYS AND COULD NOT REMOVE IT. THE SURGEON COMPLETED THE SURGERY AND CLOSED THE PATIENT UP. THERE WAS A 2-HOUR DELAY AND ADDITIONAL ANESTHESIA WAS ADMINISTERED. A CONSIGNMENT SET WAS USED.

    Patient problems: Insufficient Information

    MAUDE report 16807311 ↗

Other Orthopedic Manual Surgical Instrument devices

All Orthopedic Manual Surgical Instrument devices →

Sources and updates

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