LCS COMPLETE AOX 1294-18-517Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10603295024255), received between Jul 31, 2020 and Jul 31, 2020 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJul 31, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRIMARY SURGERY WAS OF THE LEFT KNEE ON (B)(6) 2020. PATIENT DEVELOPED A HEMATOMA. SO SURGEON PERFORMED AN I&D ON (B)(6) 2020 AND EXCHANGED THE POLY LINER. ATTACHED IS THE DGR FROM ORIGINAL SURGERY WITH THE REMAINING COMPONENTS. I HAVE NO FURTHER INFORMATION TO ADD. DID THE PATIENT EXPERIENCE A POST-OP DEVICE MALFUNCTION?: NO, DID THE PATIENT EXPERIENCE AN ADVERSE EVENT SUCH AS INFECTION, NON-UNION, ALLERGIC REACTION, OSTEOPOROSIS, OVERLOADING, PAIN, DEGENERATIVE DISEASES, BLEEDING OR OOZING?: YES, DID THE PATIENT REQUIRE REVISION SURGERY OR HARDWARE REMOVAL?: YES, FACILITY NAME OF ORIGINAL IMPLANT: DCH, WAS DEVICE EXPLANTED?: TRUE, HARDWARE/EXPLANT REMOVAL DUE TO: HEMATOMA AND NEED TO PERFORM A COMPLETE IRRIGATION, DID PATIENT REQUIRE REVISION SURGERY?: TRUE, IF YES, DATE OF REVISION SURGERY: 7/20/2020, REASON FOR REVISION SURGERY: EVACUATION OF A HEMATOMA, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?: HEMATOMA, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: EVACUATION OF

  Patient problems: No Code Available

  MAUDE report 10351382 ↗