LCS COMPLETE 1294-09-370Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295022466), received between Aug 14, 2024 and Mar 26, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 26, 2026Naturally Worn

  SURGEON IS ORDERING A PATIENT-SPECIFIC PATELLA-INLAY FOR A PLANNED REVISION BECAUSE OF NORMAL AND EXPECTED PE-WEAR. THERE HAS BEEN NO ALLEGATION OF ANY PRODUCT DEFICIENCY. THERE IS NO PATIENT OR USER HARM. DOI: >15 YRS AGO. DOR: PLANNED TO TAKE PLACE AS SOON AS POSSIBLE. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 24702247 ↗
• InjuryDec 19, 2024Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  MEDICAL RECORDS RECEIVED. DOI: (B)(6) 2016: 65-YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION OF UNKNOWN IMPLANTS TO TREAT TIBIAL TRAY LOOSENING, METALLOSIS, AND OSTEOLYSIS. THE IMPLANTS REVISED IN THIS PROCEDURE ARE UNKNOWN AND WILL NOT BE CAPTURED AS A COMPLAINT. THE PATIENT RECEIVED A TC3 REVISION KNEE, DEPUY RESURFACED PATELLA, AND DEPUY CEMENT X 4. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOR: (B)(6) 2023: 73- YEAR-OLD MALE PATIENT RECEIVED A RIGHT KNEE REVISION TO TREAT PROGRESSIVE PAIN, SWELLING, WALKING DIFFICULTY, AND STIFFNESS. UPON ENTERING THE JOINT, THE SURGEON DEBRIDED METALLOSIS AND SYNOVITIS. THE SURGEON DETERMINED THE CAUSE OF THE METALLOSIS WAS THE DISASSOCIATION OF THE FEMORAL ADAPTOR AND ADAPTOR BOLT, CAUSING MOVEMENT AT THE ADAPTOR AND BOLT JUNCTION. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED FEMORAL COMPONENT. THE FEMORAL SLEEVE AND STEM WERE WELL-FIXED AND RETAINED. THE PATELLA WAS LOOSENED AT AN UNKNOWN INTERFACE SECONDARY TO PATELLAR OSTEOLYSIS AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THE TIBIAL TRAY, SLEEVE, AND STEM WERE WELL-FIXED AND RETAINED. THERE WAS SOME MEDIAL TIBIAL OSTEOLYSIS T

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Synovitis

  MAUDE report 20975462 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DR. PERFORMED AN IRRIGATION AND DEBRIDEMENT (I&D) OF AN INFECTED RIGHT KNEE THAT HAD A ZIMMER PERSONAL KNEE SYSTEM AND A LCS COMPLETE LRG+ PATELLA. SURGEON EXPLANTED PERSONA POLY AND DEPUY LCS PATELLA POLY, WASHED OUT, AND PLACED FRESH POLYS. NO DELAY OF SURGERY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 19982614 ↗