LCS COMPLETE 1294-05-520Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295022121), received between Aug 18, 2017 and Oct 18, 2023 — classified as 5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2023Unintended Movement; Unintended Movement

  REMOVAL OF ORIGINAL POLY DUE TO SPIN-OUT. REVISED AND PUT IN A LARGER POLY. DOI: (B)(6) 2018, DOE: (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 17956348 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LCS REVISION DUE TO INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15735522 ↗
• InjuryJul 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. THE SURGEON EXPLANTED POLY AND WASHED OUT KNEE CAPSULE. THERE WAS NO SURGICAL DELAY. THERE WAS NO LOOSENING REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15051673 ↗
• InjuryJul 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE ORIGINAL IMPLANTATION DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10301731 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 6805210 ↗