LCS COMPLETE 1294-01-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295021568), received between Sep 21, 2017 and Jun 24, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAS A LOOSE RIGHT TOTAL LCS KNEE DONE BY SURGEON. THE FEMUR AND TIBIA ARE REVISED. THE PATELLA WAS WELL FIXED AND RETAINED. DOI: (B)(6) 2013. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19593112 ↗
• InjuryAug 9, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD PRIMARY TKR (LCS WITH DUOFIX FEMUR). HAD PARTIAL REVISIONS FOR PAIN AND LOOSENING. DOI: (B)(6) 2008. DOE: (B)(6) 2012. AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 17486917 ↗
• InjuryDec 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT RECEIVED A LCS KNEE SOME TIME AGO (NO DETAILS AVAILABLE OF INITIAL OPERATION. BEING REVISED TO A 1ST STAGE SPACER FOR INFECTION. NO FURTHER DETAILS AVAILABLE. IF OTHER, DESCRIBE: INFECTION., IF OTHER, DESCRIBE: 1ST STAGE REVISION TO TEMPORARY SPACER - INFECTION, PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: YES, IF YES, DESCRIBE: REVISION SURGERY, OTHER INFORMATION: N/A, IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE, (B)(4). DEVICE PROPERTY OF: NONE, DEVICE IN POSSESSION OF: NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AV

  Patient problems: Unspecified Infection

  MAUDE report 15939986 ↗
• InjuryApr 2, 2020Migration; Migration

  LOOSENING OF PRIMARY FEMORAL KNEE COMPONENT WHICH WAS IMPLANTED ON (B)(6) 2017.

  Patient problems: Ambulation or Postural Difficulties; Edema; Injury; No Code Available; Pain

  MAUDE report 9916139 ↗
• InjuryFeb 14, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  TIENT HAD A REVISION OF A LCS FROM 2016, PATIENTS ORIGINAL IMPLANT WAS ONE OF THE LCS DUOFIX WHICH HE HAD ISSUES WITH. PATIENT HAD ANOTHER PRIMARY LCS CEMENTED IN 2016 AND CYSTS HAD FORMED BEHIND THE FEMORAL COMPONENT CAUSING THE FEMUR TO BECOME UNSTABLE AND LOOSE.

  Patient problems: Cyst(s); No Code Available

  MAUDE report 9714383 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FOR PAINFUL, STIFF KNEE. COMPONENTS WERE NOT LOOSE & NO INFECTION WAS PRESENT. FEMORAL COMPONENT, POLY INSERT, & PATELLA WERE REMOVED. SYNOVECTOMY, RELEASES & REMOVAL OF OSTEOPHYTES WAS PERFORMED. NEW COMPONENTS WERE IMPLANTED W/O INCIDENT. THERE IS NO OTHER INFORMATION TO BE OBTAINED.

  Patient problems: No Code Available; Pain

  MAUDE report 8431669 ↗
• InjuryJan 8, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT REVISED DUE TO LOOSE COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 8227394 ↗
• InjuryJun 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION DUE TO PAIN, INSTABILITY, AND POLY WEAR.

  Patient problems: Not Applicable; Pain

  MAUDE report 7601519 ↗
• InjuryDec 19, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN, SWELLING AND LOOSENING OF THE FEMORAL COMPONENT AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. IT WAS ALSO NOTED THAT THERE WAS A SIGNIFICANT BONE FORMATION ON THE LATERAL PATELLA AS WELL AS IN THE INTERCONDYLAR NOTCH. ALTHOUGH THE LCS FEMORAL COMPONENT WAS WELL BALANCED AND FIT WELL IN THE AP DIMENSION, THE COMPONENT WAS FOUND TO BE OVERHANGING LATERALLY. DOI: (B)(6) 2005; DOR: (B)(6) 2017. RIGHT KNEE.

  Patient problems: Pain; Swelling

  MAUDE report 7128683 ↗
• InjuryNov 15, 2017Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL RIGHT KNEE AND ASEPTIC FEMORAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Failure of Implant; Pain

  MAUDE report 7033210 ↗
• InjurySep 21, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE PATIENT FELL AND BROKE HER FEMUR. DOING A FEMORAL REPLACEMENT (LPS).

  Patient problems: Bone Fracture(s)

  MAUDE report 6883373 ↗