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SIGMA LCS HIGH PERFORMANCE 9505-02-034Recalls & reported problems

Depuy Orthopaedics, Inc. · SIGMA LCS HIGH PERFORMANCE DUOFIX TIBIAL CENTRAL DRILL · Class 1

All models of SIGMA LCS HIGH PERFORMANCE (8)

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 10603295227533), received between Jun 4, 2020 and Jun 4, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (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

  • Dull, Blunt1
  • Naturally Worn1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

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

  • MalfunctionJun 4, 2020Dull, Blunt; Naturally Worn; Dull, Blunt; Naturally Worn

    HOSPITAL REPORTED DAMAGED INSTRUMENTS THAT NEED REPLACEMENT.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 10119067 ↗

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Sources and updates

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