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SIGMA 96-1674Recalls & reported problems

Depuy (Ireland) · SIGMA FEMORAL ADAPTER HOLDING CLAMP · Class 1

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295239796), received between Nov 28, 2017 and Feb 9, 2022 — classified as 2 malfunctions.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Break1
  • Device-Device Incompatibility1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionFeb 9, 2022Device-Device Incompatibility; Device-Device Incompatibility

    IT WAS REPORTED THAT THE SCREW USED TO TIGHTEN INSTRUMENT TO THE FEMORAL COMPONENT AND SLEEVE WOULD NOT LOCK ONTO THE FEMORAL COMPONENT. THERE WAS A SURGICAL DELAY OF 5 MINUTES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13497046 ↗
  • MalfunctionNov 28, 2017Break; Break

    IT WAS REPORTED THAT THE TORQUE HANDLE WAS BROKE.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7064790 ↗

Other CLAMP devices

All CLAMP devices →

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