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HIP Instruments 01.22.10.0156Recalls & reported problems

Medacta International SA · Proximal Reamer - Zimmer Hall · 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 07630040739276), received between Sep 8, 2020 and Sep 8, 2020 — classified as 1 malfunction.

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

  • Break1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

  • MalfunctionSep 8, 2020Break; Break

    DURING THE REVISION HIP SURGERY, AS THE SURGEON WAS REAMING OVER THE DISTAL STEM FOR THE PROXIMAL BODY, AND AS HE WAS REAMING THE METAL OFF THE TRIAL STEM, THE TOP OF THE REAMER SNAPPED OFF AS HE TRIED TO GET THE REAMER DOWN. THE SURGEON HAD TO USE A HIGH SPEED BURR TO COMPLETED THE CASE. THERE WAS A 1-HOUR DELAY IN THE SURGERY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ADDITIONAL ANESTHESIA WAS USED ON THE PATIENT AND A LOANER SET WAS UTILIZED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 10501584 ↗

Other Orthopedic Manual Surgical Instrument devices

All Orthopedic Manual Surgical Instrument devices →

Sources and updates

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