LCS SIGMA 1294-33-115Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295025757), received between Aug 15, 2017 and Mar 12, 2025 — classified as 16 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 12, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT UNDERWENT A PRIMARY SURGERY ON (B)(6) 2009. ON (B)(6) 2019, A REVISION SURGERY WAS PERFORMED DUE TO LOOSENING OF THE FEMORAL COMPONENT. AFTER THE SURGERY, A SECOND REVISION WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING OF THE TIBIAL TRAY. THIS REPORT CAPTURES THE LOOSENING OF THE TIBIAL TRAY WHICH OCCURRED AFTER THE SECOND REVISION SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 21586593 ↗
• InjuryMar 28, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  LITIGATION COMPLAINT RECEIVED AD 12 MAR 2024 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS, BILATERAL KNEE PAIN AND BILATERAL KNEE OSTEOARTHRITIS END-STAGE. ALL COMPONENTS IMPLANTED WERE DEPUY PRODUCTS, INCLUDING THE CEMENT AND PATELLA. ON (B)(6) 2020, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY, TO ADDRESS MECHANICAL LOOSENING OF INTERNAL RIGHT KNEE PROSTHETIC JOINT. THE SURGEON REPORTED FINDING TIBIAL TRAY LOOSENING. THE FEMORAL COMPONENT WAS WELL FIXED, BUT THERE WAS SIGNIFICANT OSTEOLYSIS BEHIND THE FEMORAL IMPLANT WITH LARGE CAVITARY DEFECT. SIGNIFICANT SYNOVITIS WAS ALSO NOTED. COMPETITOR PRODUCTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2014 DOR: (B)(6) 2020 RIGHT KNEE.

  Patient problems: Synovitis

  MAUDE report 18998787 ↗
• InjuryMar 28, 2024Migration; Migration

  THE LITIGATION COMPLAINT RECEIVED AD 12 MAR 2024 WAS REVIEWED BY THE CLINICIAN. ON (B)(6) 2014, THE PATIENT HAD A BILATERAL CEMENTED TOTAL KNEE ARTHROPLASTY TO ADDRESS, BILATERAL KNEE PAIN AND BILATERAL KNEE OSTEOARTHRITIS END-STAGE. ALL COMPONENTS IMPLANTED WERE DEPUY PRODUCTS, INCLUDING THE CEMENT AND PATELLA. ON (B)(6) 2021, THE PATIENT WAS REVISED DUE TO LEFT TOTAL KNEE ARTHROPLASTY, TO ADDRESS THE GROSS FAILURE OF THE TIBIAL TRAY WITH A WELL FIXED FEMORAL AND PATELLA COMPONENT. PRIOR TO SURGERY, THE PATIENT EXPERIENCED PAIN, INSTABILITY, AND DIFFICULTY AMBULATING. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE TIBIAL TRAY WAS GROSSLY LOOSE AND HAD COLLAPSED CAUSING SIGNIFICANT BONE LOSS ON THE ANTERIOR AND LATERAL ASPECT OF THE TIBIA. DURING THE PROCEDURE, THE SURGEON REPORTED THAT DURING IMPACTION A BONE FRACTURE ALONG THE LATERAL TIBIAL CORTEX WAS NOTED. THE TIBIAL TRAY, INSERT, AND FEMORAL COMPONENT WERE REVISED. DOI: (B)(6) 2014. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Ambulation or Postural Difficulties; Bone Fracture(s); Joint Laxity; Pain; Unspecified Musculoskeletal problem

  MAUDE report 18992358 ↗
• InjuryAug 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ARTHROFIBROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE) TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Adhesion(s)

  MAUDE report 17652041 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LCL TORE AND BECAME UNSTABLE. NO FURTHER INFORMATION IS AVAILABLE. THERE IS NO REPORTED LOOSENING. THERE IS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT.

  Patient problems: Joint Laxity

  MAUDE report 14601580 ↗
• InjuryNov 9, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT WAS REVISED DUE TO TIBIAL VARUS COLLAPSE AND ASEPTIC LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 2016 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12779467 ↗
• InjurySep 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: (B)(6) 2015. DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 10547356 ↗
• InjurySep 2, 2020Loss of or Failure to Bond; Malposition of Device; Loss of or Failure to Bond; Malposition of Device

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2011 VIA TKA. IT WAS REPORTED THAT THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 BY REPLACING THE FEMORAL COMPONENT, THE TIBIAL INSERT AND THE TIBIAL TRAY DUE TO LOOSENING OF THE IMPLANTS. THE FEMORAL IMPLANT WAS INSERTED BY FLEXED POSITION, AND THE TIBIAL IMPLANT WAS TILTED MEDIAL SIDE. THE IMPLANTS WERE LOOSED, SO THE SURGEON REMOVED THEM EASILY AND INSERTED NEW IMPLANTS. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE SURGEON THOUGHT THAT IT WAS TECHNICAL ERROR BY THE PRIMARY SURGERY¿S SURGEON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10482153 ↗
• InjuryJul 7, 2020Loss of or Failure to Bond; Naturally Worn; Loss of or Failure to Bond; Naturally Worn

  THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2008 VIA TKA. IN JUNE 2020, THE PATIENT COMPLAINED OF A MALFUNCTION. ON (B)(6) 2020, THE REVISION SURGERY WAS PERFORMED BY REPLACING THE TIBIAL TRAY (P/N: 129433115) AND THE TIBIAL INSERT (P/N: 951015). THE SURGEON REPLACED NATURAL PATELLA WITH A PATELLA COMPONENT. DURING THE SURGERY, THE SURGEON CONFIRMED THE WEAR OF THE TIBIAL INSERT AND THE LOOSENING OF THE TIBIAL TRAY. THE FEMORAL COMPONENT WAS NOT LOOSENED. A LITTLE WEAR WAS SEEMED AT THE EXPLANTED TIBIAL TRAY¿S SURFACE, AND THE SURGEON CHECKED DAMAGE LEVEL OF THE IMPLANTS, HE JUDGED THAT THERE WAS NO COMPLAINT ABOUT THE IMPLANTS. THE REVISION SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available

  MAUDE report 10240405 ↗
• InjuryJun 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2018; DOR: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10133788 ↗
• InjurySep 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO ROTATING PLATFORM POLYETHYLENE SPIN OUT AND INSTABILITY. DOI: (B)(6) 2012. DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9083792 ↗
• InjuryAug 24, 2018Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT HAD BILATERAL KNEES DONE IN (B)(6). THE LEFT KNEE IS PAINFUL AND TIBIAL TRAY HAS FALLEN INTO VARUS. THE SURGEON REVISED THE TIBIAL TRAY TO ADDRESS LOOSENING AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE TIBIAL INSERT WAS PITTED AND YELLOW WHERE THE FEMORAL COMPONENT ARTICULATED WITH IT. THE SURGEON BELIEVED SOME OF THIS WAS DUE TO THE KNEE BEING LOOSE AND BANGING/HITTING OF THE POLY BY THE FEMUR. THE FEMUR AND PATELLA WERE WELL FIXED AND RETAINED. DOI: (B)(6) 2015; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7812711 ↗
• InjuryMay 14, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS TIBIAL LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7511211 ↗
• InjuryApr 16, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSE TIBIA AT THE CEMENT TO IMPLANT INTERFACE, DEPUY CEMENT WAS USED. DOI: (B)(6) 2012; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7432743 ↗
• InjuryFeb 14, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES THAT THE TIBIA AND FEMUR WAS LOOSE. IT APPEARED THE CEMENT DID NOT STAY ON THE FEMUR AND CEMENT DID STAY ON THE TIBIA, BUT NOT THE BONE. HE REVISED WITH A TC3 FEMUR WITH STEM AND A MBT REVISION TIBIA TRAY WITH SLEEVE AND STEM. BONE TO CEMENT, CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2013; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269399 ↗
• InjuryAug 15, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES SIZE 1.5 SIGMA RP TIBIAL TRAY BECAME LOOSE AT BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACE. COMPETITOR CEMENT WAS USED. IT ALSO NOTED THAT LITTLE BONE CEMENT WAS ON COMPONENT UPON EXTRACTION.

  Patient problems: No Information

  MAUDE report 6796154 ↗