LCS COMPLETE 1294-01-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10603295021575), received between Apr 2, 2018 and Feb 9, 2026 — classified as 19 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 9, 2026Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  REVISION OF LCS BEARING DUE TO INSTABILITY. THE BEARING THICKNESS NEEDED TO BE THICKER TO INCREASE STABILITY. BEARING WAS UPSIZED FROM 10MM TO 15MM. NO OTHER COMPONENTS WERE REVISED.

  Patient problems: Joint Laxity

  MAUDE report 24292032 ↗
• InjuryJul 11, 2025Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF LCS FEMUR AND TIBIA TO ATTUNE REVISION WITH REVISION TIBIA AND FEMUR WITH AUGMENTS ON FEMUR + SLEEVE AND STEM. TIBIA USED SLEEVE + STEM. FEMUR HAD BONY INGROWTH BUT THE TIBIA APPEARED TO HAVE NO BONY INGROWTH. REVISED DUE TO EXPECTED TIBIAL LOOSENING-DEMONSTRATED BY THE LACK OF BONY INGROWTH. LOOSENING WAS AT IMPLANT TO BONE INTERFACE. FEMORAL COMPONENT WAS NOT LOOSE BUT WAS NOT EXTREMELY WELL FIXED EITHER.

  Patient problems: Inadequate Osseointegration

  MAUDE report 22479712 ↗
• InjuryDec 22, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  REVISION LEFT KNEE . PRIMARY IMPLANTS - RIGHT LCS FEMUR, 12.5MM INSERT AND SIZE 5 TIBIA . REVISION FOR SUBSIDENCE AND LOOSENING OF COMPONENTS . FEMUR REMOVED BY HAND - CLEAN (CEMENT LEFT ON BONE - NO CEMENT DETAILS AVAILABLE). TIBIA REMOVED VERY EASILY AS WELL WITH CEMENT ALL ATTACHED TO BONE AND NOT IMPLANT DARK METALLOSIS APPEARED ON KNEE TISSUE, NO SIGNS OF INFECTION. SURGEON WASHED, DEBRIDED THEN REVISED USING ATTUNE REVISION.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 18383118 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAINFUL KNEE. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. DOI: (B)(6) 2003. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 17703498 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ALL IMPLANTS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15666300 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHANGED LCS IMPLANTS FOR INFECTION. IT WAS UNKNOWN IF ANY LOOSENING. IT WAS UNKNOWN IF ANY SURGICAL DELAY REPORTED. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15282317 ↗
• InjuryMar 8, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION COMPLETED DUE TO AN UNSTABLE KNEE AND LOOSENING OF THE FEMORAL AND THE TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN BONE CEMENT WAS USED. NO SURGICAL DELAY. DOI: (B)(6) 2012. DOE: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 13693636 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD A POLY SWAP DONE ON (B)(6) 2021 AND REMAINS INFECTED. DOING A EXPLANT OF TOTAL KNEE WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2020 (FEMORAL & TIBIAL TRAY), (B)(6) 2021 (TIBIAL INSERT), DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 12719827 ↗
• InjurySep 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. UNKNOWN BONE CEMENT WAS USED. OSTEOLYSIS WAS ALSO NOTED. DOI: 2000, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12485954 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TIGHT IN EXTENSION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2020 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 10936789 ↗
• InjuryNov 23, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. AN UNKNOWN CEMENT WAS USED. DOI: UNKNOWN; DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 10889236 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS INFECTED. EXPLANTED COMPONENTS AND PUTTING IN STATIC SPACER WAS DONE. DOI: (B)(6), 2020. DOR: (B)(6) 2020. RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10540156 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10028907 ↗
• InjuryFeb 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND SCAR TISSUE. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: Adhesion(s); No Code Available

  MAUDE report 9770034 ↗
• InjuryNov 19, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AND TIBIA COMPONENTS AT THE CEMENT TI IMPLANT INTERFACE. ALL COMPONENTS WERE REMOVED AND REPLACED. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2013; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9343447 ↗
• InjuryAug 12, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. BOTH THE TIBIAL AND PATELLA COMPONENTS REMAINED. DOI: (B)(6) 2015. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8885699 ↗
• InjuryMay 4, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DER STATES THAT THE PATIENT HAD A LCS TOTAL KNEE REPLACEMENT. THE TIBIAL INSERT LATER SPUN AND DISLOCATED. SURGEON REVISED DUE TO WHAT HE DETERMINED TO BE AN INADEQUATE BALANCE BETWEEN THE FLEXION AND EXTENSION GAPS. THE FEMORAL COMPONENT AND TIBIAL INSERT WERE REMOVED AND IT WAS REVISED USING THE PFC SIGMA REVISION SYSTEM. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7486614 ↗
• InjuryApr 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  RIGHT KNEE REVISION. PATIENT COMPLAINED OF PAIN, SWELLING AND EFFUSIONS. REMOVED ALL IMPLANTS. ORIGINAL DATE OF SURGERY IS UNKNOWN. PATIENT CONSEQUENCE?: UNKNOWN. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Not Applicable; Pain; Swelling

  MAUDE report 7468101 ↗
• InjuryApr 2, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE. EXPLANTED AND PUT IN CEMENT SPACER. DOI: (B)(6) 2014. DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7388072 ↗