LCS COMPLETE AOX 1294-18-512Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295024231), received between Jan 29, 2018 and Oct 15, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 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.

• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE BECAME UNSTABLE. SURGEON ATTEMPTED TO SWAP THE POLY FOR A LARGER SIZE BUT HAD TO REMOVE/REPLACE THE FEMUR AND POLY. DOI: (B)(6) 2017, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23286474 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT ORTHOPEDIC SURGERY ON OR ABOUT (B)(6), 2017 AND (B)(6), 2017, AND WAS IMPLANTED WITH DEPUY SYNTHES DEVICES WHICH SUBSEQUENTLY MALFUNCTIONED OR FAILED, CAUSING PLAINTIFF INJURIES, DEBILITATION AND NECESSITATING FURTHER MEDICAL INTERVENTIONS.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 8448015 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS REMOVED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7224325 ↗