LCS COMPLETE 1294-01-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295021551), received between Sep 1, 2017 and Jun 11, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryJun 11, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT REVISION OF A CEMENTED LCS TKR, DUE TO POLY WEAR, RESULTING IN LYSIS AND COMPONENT LOOSENING FROM POLY DEBRIS. THE SURGEON NOTED THAT IT WAS IMPLANTED IN 1995. UPON EXPOSURE, POLY FRAGMENTS WERE FOUND IN THE KNEE. MINOR BONE LOSS ON MEDIAL TIBIA. SIGNIFICANT FEMORAL BONE LOSS. FEMUR, INSERT, AND TIBIA WERE REMOVED. DOI: UNKNOWN 1995, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT.

  Patient problems: Bone Notching

  MAUDE report 22183826 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE PAIN AND INSTABILITY. DOI: UNKNOWN , DOR: (B)(6) 2023, AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 16252032 ↗
• InjuryAug 29, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LCS FEMUR MEDIAL CONDYLE AREA FRACTURED AFTER INITIAL SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Bone Fracture(s); Insufficient Information

  MAUDE report 15311030 ↗
• InjuryApr 26, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO LOOSE PAINFUL KNEE. THERE WAS LOOSENING OF ALL COMPONENTS AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. CEMENT MANUFACTURER WAS UNKNOWN. DOI: (B)(6) 2015; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14203542 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY AND POLY SPIN OUT. NO SURGICAL DELAY. DOI: (B)(6) 2015, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14112329 ↗
• InjuryJan 27, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2007, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11236753 ↗
• InjuryJan 26, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS A PERIPROSTHETIC FRACTURE AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2020. DOR: (B)(6) 2021; RIGHT KNEE.

  Patient problems: Bone Fracture(s)

  MAUDE report 11231060 ↗
• InjuryOct 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LACK OF FLEXION, PAIN AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2013. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 10650949 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL PARTS EXPLANTED AND REPLACED WITH A STATIC SPACER. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10595773 ↗
• InjuryAug 4, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT RECEIVED A RIGHT PRIMARY LCS TO TREAT PAIN SECONDARY TO END-STAGE DEGENERATIVE JOINT DISEASE. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE SURGEON NOTES THERE WAS SEVERE PATELLAR AND TIBIAL DEGENERATION. THE PCL, ACL, AND IT BAND REQUIRED RELEASE TO TREAT THE PATIENT¿S NATURAL TIBIAL VALGUS. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. PATIENT RECEIVED A RIGHT TKA REVISION TO TREAT PAIN AND SWELLING SECONDARY TO FEMORAL COMPONENT LOOSENING. UPON ENTERING THE JOINT, THE SURGEON IDENTIFIED AND EVACUATED BLOOD-TINGED FLUID AND SYNOVIAL TISSUE CONSISTENT WITH FOREIGN BODY REACTION. THE FEMORAL COMPONENT WAS LOOSENED AT AN UNKNOWN INTERFACE. THERE WAS NOTED FOREIGN BODY REACTIVE FLUID AT THE DISTAL FEMORAL FLANGE. THE PATELLA AND TIBIAL TRAY WERE WELL-FIXED AND RETAINED. THERE WAS MINIMAL WEAR NOTED ON THE REVISED TIBIAL INSERT. THE PATIENT WAS REVISED WITH DEPUY COMPONENTS UTILIZING COMPETITOR CEMENT. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOI: (B)(6) 2013. DOI: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Edema; Foreign Body Reaction; No Code Available; Pain

  MAUDE report 10362370 ↗
• InjuryJul 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. NO SURGICAL DELAY. DOI: (B)(6) 2006. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10256070 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOME OF THE PROBLEMS I'VE HAD PHYSICALLY SINCE THIS IMPLANT, AND SPECIFICALLY SINCE 2016 ARE: HEART FLUTTERING, HEARTBURN, KIDNEY/LIVER READING ELEVATED, SKIN RASHES AND ITCHING, HEADACHES, CONTINUAL COUGHING, NODUAL IN THROAT, AT TIMES, PAIN IN LEFT KNEE, STRUGGLE TO WALK, ACHY JOINTS, TINNITUS, VISION ISSUES. DOI: (B)(6) 2006. DOR: REVISION SCHEDULE (A FEW MONTHS LATER). RIGHT KNEE.

  Patient problems: Headache; Heartburn/Indigestion; Itching Sensation; No Code Available; Pain; Rash; Tinnitus

  MAUDE report 10072431 ↗
• InjuryMay 1, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. IT WAS DONE 10 YEARS AGO. DON'T KNOW WHO THE SURGEON WAS OR WHERE IT WAS DONE. COULD NOT READ THE PART NUMBER ON THE FEMUR. DOI: 10 YEARS AGO. DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8569307 ↗
• InjuryApr 25, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAD TKA REVISION FOR LOOSE COMPONENTS. THERE WAS NO INFECTION PRESENT. LOOSENING HAPPENED AT CEMENT TO IMPLANT INTERFACE. DATE OF ORIGINAL SURGERY IS UNKNOWN. CEMENT USED IS UNKNOWN. COMPONENTS WERE REMOVED AND REVISION COMPONENTS WERE IMPLANTED. THERE WERE NO ADVERSE EVENTS OR ANYTHING OF CONSEQUENCE TO REPORT. THERE IS NO OTHER INFORMATION TO BE OBTAINED DUE TO PATIENT PRIVACY. NO OTHER INFO WILL BE GIVEN.

  Patient problems: No Code Available

  MAUDE report 8549985 ↗
• InjuryApr 23, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8539690 ↗
• InjurySep 1, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING. IT WAS ALSO REPORTED THAT THE PATIENT FELL SEVERAL MONTHS AGO WITH THE TIBIAL COMPONENTS HAVE FALLEN INTO THE VARUS. LOOSENING OCCURED AT UNKNOWN INTERFACE.

  Patient problems: Fall; Pain

  MAUDE report 6838303 ↗