LCS COMPLETION 2178-61-100Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295096016), received between Jan 22, 2019 and May 13, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2020Device-Device Incompatibility; Device-Device Incompatibility

  SURGEON WAS UNABLE TO CONNECT THE SAMPLE SLEEVE TO THE SAMPLE FEMUR WITH THE USE OF SCREW: 217861100. ALLEGATION AGAINST THE SCREW 217861100. PATIENT: (B)(6). SURGERY DELAY: 20MIN. NO ADVERSE PATIENT HARM. SURGERY PERFORMED: MBT REVISION AND LCS VVC BY LYING SPACER. SURGERY SUCCESSFULLY COMPLETED.

  Patient problems: Not Applicable

  MAUDE report 10052543 ↗
• MalfunctionMar 25, 2020Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHEN THEY WERE USING THE TRIAL STEM, THEY NOTICED THE LOCKING PEGS WERE BENT. WHEN THEY WERE ASSEMBLING THE TRIAL THEY NOTICED THAT THE SCREW WOULD NOT SEAT INTO THE SLEEVES. WHEN IMPACTING FINAL TIBIAL IMPLANT 2 IMPACTORS BROKE. ALL INSTRUMENTS HAVE BEEN DISCARDED. NO SURGICAL DELAY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9879431 ↗
• MalfunctionJan 22, 2019Naturally Worn; Naturally Worn

  REVISION FEMORAL SLEEVE TRIAL ATTACHMENT SCREW STRIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8267866 ↗