LCS COMPLETE 1294-12-070Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295022954), received between Dec 22, 2017 and May 23, 2019 — classified as 2 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: (B)(6) 2009; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8638043 ↗
• InjuryDec 22, 2017Loss of or Failure to Bond; Loose or Intermittent Connection; Insufficient Device Problem Information; Loss of or Failure to Bond; Loose or Intermittent Connection; Insufficient Device Problem Information

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES PAIN, INJURY, SWELLING, STIFFNESS, WEAKNESS, DISCOMFORT, EMOTIONAL DISTRESS AND EFFUSION IN THE LEFT KNEE WITH DOCUMENTED INFECTION. IT WAS ALSO CONFIRMED THAT THE INDICATION FOR SURGERY WAS "THE LEFT TKR WITH ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS."

  Patient problems: Discomfort; Distress; Injury; Joint Disorder; Loss of Range of Motion; Muscular Rigidity; No Code Available; Pain; Swelling; Unspecified Infection; Weakness

  MAUDE report 7141847 ↗