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LCS COMPLETION 2178-63-135Recalls & reported problems

Depuy (Ireland) · LCS Completion REV FEM STEM/ADAPT CLAMP 13mm · Class 1

Adverse event reports
4
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295096245), received between Jun 4, 2018 and Nov 29, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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

  • Break2
  • Material Deformation1
  • Mechanical Jam1
  • Mechanical Problem1
  • Naturally Worn1
  • Physical Resistance/Sticking1

Patient problems

  • No Consequences Or Impact To Patient3
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • MalfunctionNov 29, 2022Break; Break

    IT WAS REPORTED THAT THE TIBIAL A SLEEVE WRENCH BROKEN AND SIZE 4 8MM AUGMENT BROKE DURING TRIALING. SURGICAL DELAY WAS UNKNOWN.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15876505 ↗
  • MalfunctionNov 12, 2019Mechanical Jam; Physical Resistance/Sticking; Mechanical Jam; Physical Resistance/Sticking

    IT WAS REPORTED THAT THE HANDLE OF THE REV FEM STEM/ADAPT CLAMP WAS STUCK. THIS WAS FOUND DURING INSPECTION.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 9310983 ↗
  • MalfunctionJul 29, 2019Mechanical Problem; Material Deformation; Naturally Worn; Mechanical Problem; Material Deformation; Naturally Worn

    IT WAS REPORTED THAT THE BEVEL ON CLAMP IS WORN AND WOULD NOT LOCK DOWN ON IMPLANT TO TIGHTEN. NO SURGICAL DELAY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 8835929 ↗
  • MalfunctionJun 4, 2018Break; Break

    IT WAS REPORTED THAT THE HANDLE TIP BROKE OFF WHEN TIGHTENING IMPLANTS. NO SURGICAL DELAY. ALL PIECES WERE RETRIEVED.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7564890 ↗

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.