LCS COMPLETE 1294-05-510Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295022084), received between Jul 20, 2017 and Aug 25, 2026 — classified as 45 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (11 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryAug 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported the patient underwent a revision procedure due to osteolysis and lateral distal bone loss on the femur. The LCS tibia was left insitu and Attune PS femur & Attune PS RP bearing + Attune Dome Patella were implanted with cement even though the surgeon was informed this was considered off label use. The bearing was able to fit into the tibia and was tested prior to implantation, however, due to the patient's scar tissues being very tight the surgeon had to trim the bearing to get access and fit it in and get around the condyles of the new femoral component; he was informed this was also off label use.

  Patient problems: Adhesion(s); Osteolysis

  MAUDE report 50437829 ↗
• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD AN LEFT LCS KNEE IN FOR 20+ YEARS, STARTED TO HAVE SOME PAIN. SURGEON WANTED TO DO A SYNOVECTOMY AND A POLY SWAP TO CLEAN OUT THE BACK OF THE KNEE. THE OLD POLY LOOKED GREAT STILL AFTER 20 YEARS. SURGEON CLOSED THE PATIENT AND WAS HAPPY WITH THE STABILITY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 25434027 ↗
• InjuryMar 6, 2026Naturally Worn

  IT WAS REPORTED THAT WORN POLY ON LATERAL SIDE WITH SMALL AMOUNT OF INSTABILITY. REPLACED WITH THICKER POLY. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24536233 ↗
• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT'S KNEE WAS TIGHT WITH LIMITED RANGE OF MOTION (ROM). SURGEON PERFORMED A DEBRIDEMENT AND REPLACED POLY INSERT. THERE WERE NO DELAYS AND NO HARM TO THE PATIENT. DOI: (B)(6) 2014. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Loss of Range of Motion

  MAUDE report 24315930 ↗
• InjuryDec 4, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF LCS DUE TO BEARING WEARING OUT PARTICULARLY ON THE MEDIAL SIDE. THIS HAS BEEN IMPLANTED INSITU FOR A SIGNIFICANT AMOUNT OF TIME. PATIENT UNDERWENT A REVISION FROM LCS TO ATTUNE REVISION USING A STEM AND SLEEVE ON THE FEMUR & TIBIA. SURGERY WAS SUCCESSFUL AND SURGEON WAS HAPPY WITH THE BALANCE AT THE END OF THE CASE.

  Patient problems: Insufficient Information

  MAUDE report 23720875 ↗
• InjurySep 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LCS WAS STILL IMPLANTED DUE TO LENGTH OF IMPLANTATION PERIOD. POLYETHYLENE INLAY WORN THROUGH, MATERIAL WEAR DUE TO LONG WEARING TIME. PATIENT NEEDS CHANGE OF INLAY AND PATELLA.

  Patient problems: Insufficient Information

  MAUDE report 23082446 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA FOR OA ON THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY AND THE TIBIAL TRAY WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. ON (B)(6) 2025, THE PATIENT WAS IN PAIN AND WAS EXAMINED, WHICH REVEALED A SUSPECTED INFECTION. IMPLANT REMOVAL IS PLANNED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23015747 ↗
• InjuryOct 21, 2024Naturally Worn; Naturally Worn

  ADDITIONAL EVENT INFORMATION STATES THAT THERE WAS NO ADVERSE EVENTS AND NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20494770 ↗
• InjuryAug 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE ORIGINAL SURGERY THE PATELLA WAS LEFT NATIVE. FOR THIS REVISION THE PATELLA WAS RESURFACED WITH A SIGMA OVAL DOME PATELLA 35MM.

  Patient problems: Osteolysis; Pain

  MAUDE report 20088068 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS IMPLANTS. IMPLANTS LOOSENED DUE TO POOR POSITIONING DURING INITIAL PRIMARY PROCEDURE. THERE WAS METALOSIS SHOWING IN THE JOINT. IMPLANTS WERE TAKEN OUT VERY EASILY. EXACT DATE UNKNOWN.

  Patient problems: Pain

  MAUDE report 19271704 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. NO FURTHER INFORMATION IS AVAILABLE. DOI- (B)(6) 2007. DOR- (B)(6) 2024. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 19089639 ↗
• InjuryJan 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUIRED WASHOUT AND REPLACEMENT OF LCS INSERT DUE INFECTION WITHIN THE JOINT. ORIGIN OF THE INFECTION CURRENTLY UNKNOWN. THIS INSERT WAS REMOVED, PHOTOS TAKEN AND THE INSERT DISPOSED OF AS THE STERILE SERVICES DID NOT HAVE CAPACITY TO PROCESS. DOI: (B)(6) 2005. DOE: (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 18570601 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DR BOOKED REVISION TKR FOR (B)(6) 2023. PREVIOUS USAGE STATES LCS DUOFIX FEMUR. UNSURE ON REASON FOR REVISION AT THIS STAGE. PLANS TO CHANGE POLYETHYLENE AND RESURFACE PATELLA. PATIENT STATUS/ OUTCOME / CONSEQUENCES? WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY ? UNKNOWN. (B)(6). DEVICE PROPERTY OF ? NONE. DEVICE IN POSSESSION OF ? NONE. (B)(6). DEVICE PROPERTY OF ? NONE. DEVICE IN POSSESSION OF ? NONE. (B)(6). 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 AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST? TRUE.

  Patient problems: Pain

  MAUDE report 17190508 ↗
• InjuryMay 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CHANGE OF LEFT TN LCS MBT TIBIA AFTER THE PATIENT FALLS. PRIMARY PROSTHESIS WAS IMPLANTED IN 2017. DOI: 2017; LEFT KNEE.

  Patient problems: Fall

  MAUDE report 16866919 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. ORIGINAL IMPLANTATION WAS APPROXIMATELY 22-25 YEARS AGO. NO FURTHER INFORMATION IS AVAILABLE. DOI: APPROX 22-25 YEARS AGO. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16816878 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION FOR INFECTION, 8 YEAR POST IMPLANTATION. IMPLANT DISPOSED OF AT HOSPITAL. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? UNKNOWN. WERE FRAGMENTS GENERATED? UNKNOWN. IF YES, WERE THEY REMOVED EASILY WITHOUT ADDITIONAL INTERVENTION? UNKNOWN. PATIENT STATUS/ OUTCOME / CONSEQUENCES: NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY: UNKNOWN. (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 AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.: TRUE.

  Patient problems: Unspecified Infection

  MAUDE report 16016279 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO POSSIBLE INFECTION. THE SURGEON DECIDED TO CHANGE THE INSERT AND RESURFACE PATELLA. THE PATELLA WAS NOT ORIGINALLY DONE IN THE 1ST SURGERY IN 2017.

  Patient problems: Unspecified Infection

  MAUDE report 15987564 ↗
• 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. IP-01588170. DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01588171. DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01588172. DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01588173. DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01588174. DEVICE PROPERTY OF: NONE. DEVICE IN POSSESSION OF: NONE. IP-01588175. 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 NE

  Patient problems: Unspecified Infection

  MAUDE report 15939914 ↗
• InjuryOct 7, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED WITH PAINFUL LEFT KNEE WITH POLY WEAR. NO PREVIOUS SURGERY DATE WAS AVAILABLE. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 15563814 ↗
• InjuryOct 6, 2022Naturally Worn; Naturally Worn

  LCS COMPLETE POLY LINER AND PATELLA REVISION IMPLANT CURRENTLY IN SITU HAD WEAR AND DELAMINATION ON BOTH IMPLANT COMPONENTS. PREVIOUS OPERATION WAS COMPLETE IN 2011. PATIENT EXPERIENCED PAIN DUE TO WEAR ON POLY AND PATELLA. REVISION TOOK PLACE ON (B)(6) 2022. NEW TIBIAL INSERT AND PATELLA PUT IN. DOI: (B)(6) 2011. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15554579 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE. WASHED IT OUT AND CHANGED THE INSERT. NO FURTHER INFORMATION IS AVAILABLE. AND THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15209670 ↗
• InjuryMay 25, 2022Naturally Worn; Naturally Worn

  PATIENT PRESENTED WITH PAIN IN THEIR RIGHT KNEE APPROXIMATELY THIRTEEN YEARS AFTER PRIMARY TOTAL KNEE REPLACEMENT. PRIMARY KNEE REPLACEMENT TOOK PLACE ON THE 30TH (B)(6)2009. SURGEON REFERRED PATIENT FOR AN X-RAY. X-RAY INDICATED THAT THE FEMORAL TIBIAL GAP WAS ASYMMETRIC, SMALLER GAP MEDIALLY COMPARED TO LATERAL SIDE. SURGEON DETERMINED THAT THIS COULD BE A RESULT OF WEAR TO THE MEDIAL PORTION OF THE POLYETHYLENE INSERT AND THE PAIN A RESULT OF SYNOVITIS AS A RESULT OF THE POLYETHYLENE DEBRIS. SURGEONS DETERMINATION SEEMED CORRECT AS SUBSTANTIAL SYNOVITIS AND MEDIAL DAMAGED TO THE POLYETHYLENE INSERT. SYNOVECTOMY PERFORMED TO REMOVE ALL THE SYNOVITIS AND A REPLACEMENT POLYETHYLENE INSERT IMPLANTED. DOI: (B)(6) 2009. DOR: (B)(6) 2022. RIGHT KNEE.

  Patient problems: Pain; Synovitis

  MAUDE report 14495305 ↗
• InjuryJan 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. IMPLANTED CIRCA 2003 AT ANOTHER FACILITY. DOI: (B)(6) 2003. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 13384974 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OS LCS PRIMARY TOTAL KNEE; REVISED FOR PAIN. NIL KNOWN DATE FOR ORIGINAL PRIMARY SURGERY; NIL KNOWN ORIGINAL SURGEON DETAILS; REVISED TO LCS REVISION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 12984688 ↗
• InjuryDec 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LCS BECAME UNSTABLE. REVISION NECESSARY. DOI: UNKNOWN. DOR: (B)(6) 2021, UNKNOWN KNEE SIDE.

  Patient problems: Joint Laxity

  MAUDE report 12909247 ↗