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LCS SIGMA 1294-33-110Recalls & reported problems

Depuy (Ireland) · LCS SIGMA TIBIAL TRAY ROTATING PLATFORM MBT KEEL SIZE 1 CEMENTED · Class 3 · Implant

All models of LCS SIGMA (15)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295025740), received between Jan 7, 2020 and Aug 10, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Loss of or Failure to Bond2

Patient problems

  • Insufficient Information1
  • No Code Available1
  • Pain1

Recent adverse event reports

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

  • InjuryAug 10, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

    THIS (B)(4) IS RELATED TO (B)(4) WHICH REPORTS THAT THE FEMORAL IMPLANTS WERE LOOSENED AFTER THE REVISION SURGERY. THIS PC REPORTS THAT THE TIBIAL IMPLANTS WERE LOOSENED AFTER THE PRIMARY SURGERY. IT WAS REPORTED THAT ON (B)(6) 2010, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE SIGMA RPF FOR THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE TIBIAL IMPLANTS WERE LOOSENED. THEREFORE, THE REVISION SURGERY (THE TKA) WAS PERFORMED ON (B)(6) 2016. THE MBT TRAY WAS REPLACED WITH THE MBT REVISION STEM, AND THE 10MM RPF INSERT WAS REPLACED WITH THE 12.5MM INSERT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2010. DOR: (B)(6)2016. UNKNOWN KNEE.

    Patient problems: Insufficient Information

    MAUDE report 15198125 ↗
  • InjuryJan 7, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

    PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT MANUFACTURER WAS USED. DOI: (B)(6) 2017. DOR: (B)(6) 2019; RIGHT KNEE.

    Patient problems: No Code Available; Pain

    MAUDE report 9558523 ↗

Other Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing devices

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Sources and updates

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