LCS SIGMA 1294-31-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295025610), received between Sep 21, 2017 and Feb 9, 2026 — classified as 24 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (10 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 24 most recent of 24 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 24292031 ↗
• 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 22479717 ↗
• InjuryMay 8, 2024Loss of or Failure to Bond; Use of Device Problem; Loss of or Failure to Bond; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED. INDICATING, THAT THERE WAS LOOSENING BETWEEN THE IMPLANT AND CEMENT.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 19272053 ↗
• InjuryFeb 22, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THERE WERE NO SURGICAL DELAYS.

  Patient problems: Foreign Body Reaction; Inflammation; Pain

  MAUDE report 16417042 ↗
• InjuryNov 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LCS REVISION DUE TO INFECTION AND PAIN.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 15734718 ↗
• InjuryAug 8, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  PFC SIGMA TOTAL LOOSENING FEMUR TIBIA PATELLA. NO INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 15182457 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED TO ADDRESS PAIN. PATELLA RESURFACING AND SOFT TISSUE RELEASE WERE COMPLETED. INSERT WAS REMOVED. INSERT WAS WORN.

  Patient problems: Pain

  MAUDE report 13078529 ↗
• InjurySep 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 12505866 ↗
• InjuryJul 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND EXPERIENCED INSTABILITY IN THE KNEE. THE DOCTOR REPLACED THE FEMUR, TIBIA AND INSERT WITH NEW COMPONENTS TO STABILIZE THE KNEE. DOI: (B)(6) 2013, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Fall; Joint Laxity

  MAUDE report 12215378 ↗
• InjuryJul 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION DUE TO INSTABILITY AND PAIN. DURING THE REVISION, SUBSTANTIAL POLY WEAR WAS NOTED ON TIBIAL INSERT AND PATELLA. THE PATELLA IMPLANT WAS LOOSE AS WELL. LOOSENING OCCURRED AT BONE TO CEMENT INTERFACE WITH AN UNKNOWN BONE CEMENT. THE EXPLANTED COMPONENTS ARE NOT AVAILABLE FOR RETURN AND PART NUMBERS WERE NOT LEGIBLE ON THE PATELLA OR FEMUR. NO OTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 12128790 ↗
• InjurySep 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. A 2ND STAGE REPLACEMENT WAS PERFORMED WHEN INFECTION WAS GONE. ORIGINAL IMPLANT DATE IS UNKNOWN. NO SURGICAL DELAY IS NOTED. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10485055 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOE: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9933347 ↗
• 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 9343454 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8146262 ↗
• InjurySep 26, 2018Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth; Loss of or Failure to Bond; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT WAS REVISED TO ADDRESS PAINFUL LEFT KNEE AND LOOSENING OF THE TIBIAL COMPONENTS AT CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available; Pain

  MAUDE report 7912871 ↗
• InjuryAug 20, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND LOOSENING OF THE TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7796826 ↗
• InjuryAug 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DOCTOR TOOK OUT THE TIBIAL IMPLANT AND INSERT IMPLANT BECAUSE THE TIBIA WAS IN VALGUS AND REPLACED WITH A FIXED BEARING TIBIAL IMPLANT AND FIXED BEARING INSERT. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN DOR: (B)(6) 2018 RIGHT SIDE.

  Patient problems: Not Applicable

  MAUDE report 7793203 ↗
• InjuryJun 20, 2018Loss of or Failure to Bond; Loose or Intermittent Connection; Migration or Expulsion of Device; Loss of or Failure to Bond; Loose or Intermittent Connection; Migration or Expulsion of Device

  DER STATES THAT THE PATIENT HAD A TIBIAL LOOSENING AND SUBSIDENCE DUE TO TIBIAL BONE LOSS. BONE DEFICIT CAUSED PATIENT DISCOMFORT WITH COMPONENT SHIFTING. DOI: UNKNOWN. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Discomfort; Injury; Not Applicable

  MAUDE report 7620496 ↗
• 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 7468179 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS REMOVED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7224296 ↗
• InjuryNov 30, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES THAT PATIENT WAS CLAIMING OF PAIN AND THE SURGEON WAS CONCERNED WITH BONE GROWTH AROUND PATELLA AS WELL AS POSSIBLE LOOSENING OF FEMORAL COMPONENT. DURING SURGERY BOTH TIBIAL AND FEMORAL COMPONENTS WERE LOOSE. CEMENT WAS FOUND BOTH ON IMPLANTS AND BONE. PATELLA WAS ALSO RESURFACED AND IMPLANT REPLACED.

  Patient problems: Pain

  MAUDE report 7072802 ↗
• InjuryOct 17, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN. PATIENT HAS REPORTED BEING UNABLE TO WALK FOR MORE THAN 50 METERS BEFORE NEEDING TO REST THEIR KNEE, DUE TO PAIN. IT WAS ALSO REPORTED THAT ON EXAMINATION IT APPEARS THAT THE KNEE IS IMBALANCED WITH THE LATERAL SIDE OPENING UP TO 7MM IN EXTENSION AND 4 MM IN FLEXION AND THE PATELLA WAS OVERHANGING ON THE MEDIAL SIDE AND APPEARED UNDERSIZED.

  Patient problems: Pain

  MAUDE report 6954578 ↗
• InjuryOct 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS WERE REMOVED. ANTIBIOTIC SPACER WAS PLACED.

  Patient problems: Unspecified Infection

  MAUDE report 6921520 ↗
• InjurySep 21, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 6881979 ↗