LCS COMPLETION 2178-55-087Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295095361), received between Sep 19, 2018 and Sep 19, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Component Missing” (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

Recent adverse event reports

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

• MalfunctionSep 19, 2018Component Missing; Appropriate Device Problem Term/Code Not Available; Component Missing; Appropriate Device Problem Term/Code Not Available

  RIGHT TOTAL KNEE ARTHROPLASTY; (B)(6), (B)(6) 2018. DURING THE PROCEDURE, THE SURGEON PERFORMED A DISTAL CUT ON THE PATIENT¿S FEMUR USING THE POP UP DISTAL CUTTING BLOCK. AT THAT MOMENT THE SAW CAPTURE CAME LOOSE AND WAS DETACHED FROM THE BLOCK. IT APPEARED TO HAVE A SCREW MISSING. THE SURGEON WAS CONFIDENT THAT THE SCREW WAS MISSING BEFORE COMMENCING WITH THE CUT. THE SCRUB NURSE AND JNJ REPRESENTATIVE WERE UNABLE TO FIND ANY SCREWS IN THE PROCEDURE TRAYS. THIS ALL HAPPENED AS THE DISTAL CUT WAS COMPLETED. THERE WAS NO ADVERSE EVENT. PATIENT OUTCOME POST SURGERY: SATISFACTORY OUTCOME AS SURGEON WAS ABLE TO COMPLETE THE PROCEDURE WITHOUT ANY FURTHER DELAY. FEMALE PATIENT ID: (B)(6).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7888759 ↗