LCS COMPLETE 1294-09-670Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295022671), received between Jun 24, 2019 and Nov 16, 2021 — classified as 3 injuries, 1 malfunction.

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.

• InjuryNov 16, 2021Osseointegration Problem; Osseointegration Problem

  REVISION KNEE SURGERY FOR ASEPTIC LOOSENING OF FEMORAL, TIBIAL AND PATELLA IMPLANTS OF THE LEFT KNEE. BONE SCANS HIGHLIGHTED "HOT" ON THE ABOVE THREE COMPONENTS. THE IMPLANTS WERE EXPLANTED AND REPLACED WITH AN ATTUNE REVISION KNEE SYSTEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12820052 ↗
• InjuryJul 15, 2021Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A BROKEN POLY ON PATELLA. ORIGINAL IMPLANT DATE IS UNKNOWN. THE INSERT WAS CHANGED BECAUSE IT WAS 16 YEARS OLD. POLY WAS FINE. NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12173716 ↗
• InjurySep 11, 2020Fracture; Fracture

  PATIENT EXPERIENCED "SUDDEN ONSET OF PAIN" IN THE KNEE A FEW WEEKS AGO AND WAS REVIEWED BY DOCTOR. THE DOCTOR SUSPECTED THERE WAS AN ISSUE WITH THE INSERT AND ELECTED TO DO A REVISION TO REPLACE THE PRIMARY INSERT (HE FELT IT MAY BE FRACTURED OR CRACKED). UPON OPENING THE KNEE THERE WAS NO OBVIOUS DAMAGE TO THE INSERT, AND DOCTOR FELT THE IMPLANT WAS IN REASONABLY GOOD CONDITION IN HIS OPINION, BUT THERE WAS SOME DAMAGE TO THE PATELLA BUTTON (CAUSE UNKNOWN). THERE WAS SIGNIFICANT SYNOVITUS SURROUNDING THE JOINT. SURGEON DEBRIDED THE AFFECTED TISSUE AND REPLACED THE INSERT AND PATELLA BUTTON. NO DETAILS WERE AVAILABLE REGARDING THE MECHANISM THAT LEAD TO THE ONSET OF PAIN (NO MENTION OF FALL OR OTHER INJURY GIVEN).

  Patient problems: Inflammation; No Code Available; Pain; Synovitis

  MAUDE report 10521652 ↗
• MalfunctionJun 24, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  AFTER OPENING IMPLANTS FOR LCS KNEE SURGEON COMMENTED ON THE PATELLA - THAT THE POLYETHYLENE ARTICULATING SURFACE FELT QUITE LOOSE AGAINST THE METAL BACK. HE HAS BEEN USING LCS FOR OVER 14 YEARS AND HAS A LOT OF EXPERIENCE AND HAD NOT NOTICED THIS ISSUE BEFORE. IT WAS A LARGE+ PATELLA AND A SIZE WE RARELY USE SO THE SURGEON PREFERRED FOR ANOTHER IMPLANT TO BE OPENED AS HE WASN'T CONFIDENT THAT THERE WAS NOT AN ISSUE WITH THE PATELLA. A NEW ONE WAS OPENED AND USED. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? YES. IF YES, NUMBER OF MINUTES: 5. ACTION TAKEN WHEN EVENT OCCURRED? --> ANOTHER PATELLA WAS OPENED AND USED. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES. WERE FRAGMENTS GENERATED? NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO,

  Patient problems: Not Applicable

  MAUDE report 8726363 ↗