LCS COMPLETE 1294-05-320Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295021988), received between Jul 1, 2021 and Oct 18, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2022Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE SURGERY WITH THE INSERT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE INSERT CAME OFF ON (B)(6) 2022. A REVISION SURGERY IS PLANNED ON (B)(6) 2022. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 15625111 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE IN EXTENSION AND FLEXION. TAKING OUT IMPLANTS AND REPLACING THEM WITH A SROM HINGE. DOI: (B)(6) 2018 DOR: (B)(6) 2021 LEFT KNEE

  Patient problems: Joint Laxity

  MAUDE report 12100358 ↗