LCS COMPLETE 1294-09-440Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295022503), received between Apr 15, 2021 and Jun 27, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 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.

• InjuryJun 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD (B)(6) 2023, WERE REVIEWED BY A CLINICIAN. PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY UTILIZING DEPUY SYNTHES IMPLANTS ON (B)(6) 2013 INCLUDING PATELLA. COMPETITOR CEMENT WAS UTILIZED. ON (B)(6) 2023, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION FOR LOOSENING. DARK STAINING OF THE SYNOVIUM WAS PRESENT WITH EXTENSIVE METALLOSIS. THE FEMORAL COMPONENT WAS LOOSE WITH NO INTERFACE CLEARLY PROVIDED. THE TIBIAL COMPONENT WAS ALSO LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE PATELLA WAS UNDERSIZED ACCORDING TO THE SURGEON AND WAS REVISED. DOI: (B)(6) 2013. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Foreign Body Reaction; Synovitis

  MAUDE report 17208738 ↗
• InjuryApr 15, 2021Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6), STUDY: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR REVISION OF LEFT PATELLOFEMORAL ARTHROPLASTY TO ADDRESS PROGRESSIVE ARTHRITIS AND POLYETHYLENE BEARING WEAR OF PATELLA COMPONENT. DATE OF IMPLANTATION: (B)(6) 2005. DATE OF REVISION: (B)(6) 2021; (LEFT KNEE). TREATMENT: PATELLOFEMORAL ARTHROPLASTY FEMUR AND PATELLA COMPONENTS REVISED.

  Patient problems: Adhesion(s); Cyst(s); Inflammation; Pain

  MAUDE report 11671389 ↗