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HIP Instruments 01.39.10.0034Recalls & reported problems

Medacta International SA · Calcar Reamer Small 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
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07630040763806), received between Nov 25, 2022 and Nov 25, 2022 — classified as 1 injury.

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

  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Bone Fracture(s)1

Recent adverse event reports

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

  • InjuryNov 25, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

    DURING THE PRIMARY HIP SURGERY, WHEN THE SURGEON WAS USING THE SMALL CALCAR PLANNER, THE ANTERIOR ASPECT OF THE FEMUR SPLIT. THE SURGEON CABLED THE FRACTURE AND CONTINUED WITH THE CASE. THERE WAS A 10-MINUTE DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. A CONSIGNMENT SET WAS UTILIZED. REAMER TEETH WERE NOT WORN, FIRST TIME USAGE. SMS 9 STD IMPLANTED (SMS 9 STD TEMPLATED).

    Patient problems: Bone Fracture(s)

    MAUDE report 15864354 ↗

Other Orthopedic Manual Surgical Instrument devices

All Orthopedic Manual Surgical Instrument devices →

Sources and updates

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