LCS COMPLETE 1294-09-450Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295022510), received between Mar 25, 2019 and Apr 29, 2022 — classified as 4 injuries.

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

Recent adverse event reports

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

• InjuryApr 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PATELLA PAIN. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN , DOR: APR 13, 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14252908 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PATELLA COMPONENT REVISED DUE TO PAINFUL KNEE AND POLY INSERT REPLACED DURING PARTIAL REVISION KNEE TODAY. DOI: (B)(6) 2009. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9375781 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SYMPTOMS CONSISTENT WITH INFECTION OF THE TOTAL KNEE. THE PATIENT HAD A FEVER AND THE OPERATIVE KNEE WAS RED AND SWOLLEN. SURGEON DREW LABS AND ASPIRATED THE KNEE. THE LABS WERE ELEVATED CONSISTENT WITH INFECTION, ALSO THE ASPIRATE GREW OUT BACTERIA. SURGEON THEN TOOK THE PATIENT TO SURGERY TO REMOVE THE IMPLANTS TO WASHOUT AND PLACE ANTIBIOTIC SPACER. IMPLANTS WERE ALL WELL FIXED. IMPLANTS WERE REMOVED WITH VERY LITTLE BONE LOSS. ANTIBIOTIC SPACERS WERE PLACED. DEPUY CEMENT WAS USED. UPDATE: DEPUY 2 CEMENT REF# (B)(4) LOT# 8770435 WAS USED DURING THE PRIMARY KNEE PROCEDURE ON (B)(6) 2019 TO CEMENT THE TIBIA AND PATELLA. THE IMPLANTS WERE FOUND TO BE WELL FIXED AT THE TIME OF THE EXPLANT PROCEDURE. DOI: (B)(6) 2019, DOR: (B)(6) 2019. LEFT KNEE.

  Patient problems: Fever; Injury; No Code Available; Swelling; Unspecified Infection

  MAUDE report 8451087 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8447710 ↗