LCS COMPLETE 1294-24-610Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295024781), received between Jul 14, 2023 and Sep 3, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (2 reports).

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.

• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 22955036 ↗
• InjuryFeb 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A RIGHT TOTAL KNEE THAT WAS INFECTED. THE SURGEON DID A WASHOUT AND REPLACED THE TIBIAL INSERT AND REMOVED THE PATELLAR COMPONENT. DOI: (B)(6) 2023. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 18748099 ↗
• InjuryOct 19, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE IMPLANT IS BROKEN. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? UNKNOWN, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT: (B)(6), WAS DEVICE EXPLANTED? TRUE, DID PATIENT REQUIRE REVISION SURGERY? TRUE, PATIENT STATUS/ OUTCOME / CONSEQUENCES , WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST. TRUE.

  Patient problems: Insufficient Information

  MAUDE report 17966792 ↗
• InjuryJul 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE LCS VVC INLAY WAS BROKEN. THE REINFORCEMENT PIN WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17324266 ↗