LCS SIGMA 1294-31-130Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10603295025603), received between Aug 11, 2017 and Dec 4, 2024 — 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.

• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF SIGMA ROTATING PLATFORM CR KNEE FOR INSTABILITY. THE TIBIA WAS DETERMINED TO BE LOOSE INTRAOPERATIVELY. LOOSE COMPONENT WAS TIBIA, LOOSENING INTERFACE WAS BONE TO CEMENT, AND THE CEMENT MANUFACTURER WAS UNKNOWN. ALL COMPONENTS WERE REMOVED IN ORDER TO PERFORM A REVISION WITH A COMPETITOR SYSTEM. THERE WAS SIGNIFICANT POLY WEAR NOTED ON THE POSTERIOR MEDIAL LIP OF THE POLY. THERE WAS NO NOTED MALPOSITION OF ANY COMPONENTS THAT LED TO THE INSTABILITY. THERE WAS NO EXCESSIVE RESECTION OF THE TIBIA OR FEMUR DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 20845506 ↗
• InjuryJun 24, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAS A LOOSE RIGHT TOTAL LCS KNEE DONE BY SURGEON. THE FEMUR AND TIBIA ARE REVISED. THE PATELLA WAS WELL FIXED AND RETAINED. DOI: (B)(6) 2013. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19593113 ↗
• InjuryOct 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE TIBIA WAS LOOSENING, AFTER 15 YEARS. THERE WAS NO SURGICAL DELAY. RIGHT KNEE PFC SIGMA. ADDITIONAL EVENT INFORMATION PROVIDED BY SALES. REP STATES LOOSENING INTERFACE WAS LOCATED AT THE CEMENT IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 17940442 ↗
• InjuryDec 6, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF LCS KNEE COMPONENTS FOR ASEPTIC LOOSENING. THREE COMPONENTS REMOVED. FEMUR, TIBIA AND INSERT.

  Patient problems: Discomfort; Pain

  MAUDE report 15923462 ↗
• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13769651 ↗
• InjurySep 24, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12526503 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRIMARY LEFT IMPLANTS ON (B)(6) 2020. SHE HAD AN I&D AND REPLACEMENT OF POLY ON 11/11 AND (B)(6) 2020. (B)(4). THIS PATIENT IS VERY SICK WITH MULTIPLE COMORBIDITIES. SHE HAD AN ABSCESS ON THE LEFT KNEE SURGICAL SITE. THERE WAS NOTICEABLE ASEPTIC LOOSENING OF THE FEMORAL AND PATELLA COMPONENTS. ALL IMPLANTS WERE REMOVED WITH NO PLAN TO REIMPLANT. SURGEON PERFORMED AN END-STAGE ARTHRODESIS. HER RIGHT KNEE WAS PERFORMED YEARS AGO AND SEEMS TO BE UNAFFECTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12480941 ↗
• InjurySep 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED IN THE LEFT KNEE DUE TO ARTHROFIBROSIS. REMOVED FEMUR, INSERT AND TRAY. ORIGINAL DOS IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Adhesion(s)

  MAUDE report 12473744 ↗
• InjuryJul 21, 2021Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT WAS REVISED TO ADDRESS A COLLAPSED TIBIAL COMPONENT AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2006, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12206615 ↗
• InjuryJul 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. ORIGINAL IMPLANT DATE IS UNKNOWN. NO DELAY IN SURGERY. DOI: UNKNOWN. DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12173996 ↗
• InjurySep 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  SUSPECTED ASEPTIC LOOSENING. SURGERY VERIFIED LOOSENING OF TIBIAL TRAY WITH DEBONDING BETWEEN METAL AND CEMENT. SOME ORSTEOLYSIS ON LATER FEMORAL CONDYLE, BUT FEMUR COMPONENT WAS NOT LOOSE. INFECTIONS TEST WHERE TAKEN AND SENT TO LAB TO VERIFY ANY INFECTION. PAT. WAS REVISED TO A ATTUNE FB REVISION KNEE. NO ADVERSE EVENTS DURING SURGERY. NO ADVERSE EVENTS DURING SURGERY.

  Patient problems: No Code Available

  MAUDE report 10502148 ↗
• 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 10072428 ↗
• InjuryMar 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF CR150 RP KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9851292 ↗
• InjuryJun 12, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THERE WAS A LOOSE TIBIA WITH A LCS RPS PRIMARY KNEE. THE MEDIAL PROX. TIBIAL BONE GAVE WAY UNDER THE TRAY CAUSING IT TO COLLAPSE. THE FEMUR LOOKED FINE BUT WAS REMOVED DUE TO LIGAMENT INSTABILITY. THE POLY SHOWED SOME PITTING BUT IT HAD BEEN IN ABOUT 10 YEARS. THE FEMUR HAD SOME LYSIS BEHIND THE FEMUR.

  Patient problems: Injury; No Code Available

  MAUDE report 8692801 ↗
• InjuryMay 9, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS ALSO REPORTED THAT THE TIBIA COLLAPSED. DOI: 2011, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8594685 ↗
• 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 8549939 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SYMPTOMS CONSISTENT WITH INFECTION OF THE TOTAL KNEE. THE PATIENT HAD A FEVER AND THE OPERATIVE KNEE WAS RED AND SWOLLEN. SURGEON DREW LABS AND ASPIRATED THE KNEE. THE LABS WERE ELEVATED CONSISTENT WITH INFECTION, ALSO THE ASPIRATE GREW OUT BACTERIA. SURGEON THEN TOOK THE PATIENT TO SURGERY TO REMOVE THE IMPLANTS TO WASHOUT AND PLACE ANTIBIOTIC SPACER. IMPLANTS WERE ALL WELL FIXED. IMPLANTS WERE REMOVED WITH VERY LITTLE BONE LOSS. ANTIBIOTIC SPACERS WERE PLACED. DEPUY CEMENT WAS USED. UPDATE: DEPUY 2 CEMENT REF# (B)(4), LOT# 8770435 WAS USED DURING THE PRIMARY KNEE PROCEDURE ON (B)(6) 2019 TO CEMENT THE TIBIA AND PATELLA. THE IMPLANTS WERE FOUND TO BE WELL FIXED AT THE TIME OF THE EXPLANT PROCEDURE. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Fever; Injury; No Code Available; Swelling; Unspecified Infection

  MAUDE report 8451090 ↗
• InjurySep 20, 2018Migration; Migration

  PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2018. RIGHT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7893048 ↗
• InjurySep 19, 2018Migration; Migration

  PATIENT WAS REVISED TO ADDRESS TIBIAL SUBSIDENCE AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 7891319 ↗
• InjuryApr 27, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT HAD KNEE REVISION DUE TO LOOSENING OF THE PRIMARY TIBIAL COMPONENT PATIENT CONSEQUENCE?: NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT?: YES.

  Patient problems: Not Applicable

  MAUDE report 7467855 ↗
• InjuryJan 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT FELL AND TIBIAL COMPONENT CAME LOOSE. HAD TO REVISE ORIGINAL SURGERY PERFORMED IN MAY. NO UNEXPECTED DELAYS IN SURGERY.

  Patient problems: Fall

  MAUDE report 7221094 ↗
• InjuryDec 22, 2017Loose or Intermittent Connection; Loose or Intermittent Connection

  PATIENT RECEIVED KNEE-TEP RIGHT SIDE IN 2008. REVISION OF INLAY AND TIBIAL PLATEAU BECAUSE OF LOOSENING ON (B)(6) 2009. AS A SIDE EFFECT SOME WEAR WAS SEEN ON THE PE-INLAY. DOI: 2008; DOR: (B)(6) 2009; RIGHT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7142077 ↗
• InjuryNov 13, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES THAT THE PATIENT HAD DEPUY LCS KNEE SYSTEM PRIOR. PATIENT WAS COMING CLOSE TO 20 YEARS OF IMPLANTATION. SURGEON DECIDED TO REMOVE THE IMPLANTS AND PUT IN NEW REVISION IMPLANTS. UPDATE OCT 26, 2017 : TIBIAL TRAY LOOSENING. LOOSENING OCCURRED FROM CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THIS COMPLAINT WAS UPDATED ON OCT 26, 2017.

  Patient problems: Joint Disorder; No Code Available; Pain

  MAUDE report 7025753 ↗
• InjuryAug 11, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS PAIN, INSTABILITY AND TIBIAL SUBSIDENCE.

  Patient problems: Pain

  MAUDE report 6787458 ↗