LCS COMPLETE 1294-24-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295024712), received between Jan 11, 2019 and May 4, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WASH OUT WITH POLY CHANGE OF THE KNEE WAS PERFORMED. AFFECTED SIDE-UNKNOWN KNEE.

  Patient problems: Insufficient Information

  MAUDE report 25067902 ↗
• InjuryOct 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS COMPLETE REVISION COMPONENTS. IMPLANTS REVISED DUE TO SUSPECTED INFECTION AND LOOSENING. VERY MINIMAL BONE GROWTH ON THE STEM AND SLEEVE. IMPLANTS WERE REMOVED VERY EASILY. DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING? NO, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL? YES, FACILITY NAME OF ORIGINAL IMPLANT WAS DEVICE EXPLANTED? TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: INFECTION AND LOOSENING, DID PATIENT REQUIRE REVISION SURGERY? TRUE, IF YES, DATE OF REVISION SURGERY. REASON FOR REVISION SURGERY. INFECTION AND LOOSENING, PATIENT STATUS/ OUTCOME / CONSEQUENCES YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? PAIN DUE TO INFECTION AND LOOSENING, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN, IS THE PATIENT PART OF A CLINICAL STUDY UNKNOWN, IP-(B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4) DEVICE PROPERTY OF NONE, DEVICE IN POSSESSION OF NONE, IP-(B)(4) DEVICE PROP

  Patient problems: Pain; Unspecified Infection

  MAUDE report 20567668 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTION DUE TO WOUND BREAKDOWN. WASHOUT AND POLY EXCHANGE OF INFECTED TKR, POLY REMOVED AND REPLACED TO ALLOW THE SURGEON ACCESS TO THE BACK OF THE KNEE AND NEW POLY INSERTED. NO AE REPORTED, NO DELAY IN THE SURGERY.

  Patient problems: No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9613562 ↗
• InjuryJan 11, 2019Fracture; Naturally Worn; Fracture; Naturally Worn

  PATIENT WAS REVISED DUE TO REDUCED MOVEMENT AND AN 'AUDIBLE CLUNK' DURING RANGE OF MOTION.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 8239654 ↗