LCS SIGMA 1294-33-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 10603295025801), received between Jul 13, 2017 and Feb 19, 2026 — classified as 128 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (51 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 129 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO ASEPTIC INSTABILITY. AFFECTED SIDE-LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 24387645 ↗
• InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT IMPLANTS WERE EXPLANTED DUE TO INFECTION. DOI- UNKNOWN. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 24071896 ↗
• InjuryDec 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ADAPTING LOOSENING OF THE TIBIAL BASEPLATE AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2009. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23769992 ↗
• InjurySep 18, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23084959 ↗
• InjurySep 2, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL LOOSENING AT CEMENT TO IMPLANT INTERFACE. ALL COMPONENTS WERE REVISED WITH NO DELAYS OR PATIENT INJURY. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 22939094 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAS SEVERE ARTHROFIBROSIS & HETEROTOPIC OSSIFICATION. IMPLANTS WERE NOT LOOSE. PRODUCTS WERE REMOVED BECAUSE THE PATIENT HAD LIMITED ROM. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Adhesion(s); Extraskeletal ossification; Loss of Range of Motion

  MAUDE report 22211208 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE. IMPLANTS WERE REMOVED. CEMENT SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21988175 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED KNEE. IMPLANTS WERE REMOVED. CEMENT SPACER WAS PUT IN. THERE WAS NO SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT. DOI: (B)(6) 2019. DOR: (B)(6) 2025. AFFECTED AREA: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21988156 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 21346178 ↗
• InjuryDec 30, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO LOOSE TIBIAL COMPONENT AND FEMORAL COMPONENT. UNKNOWN LOOSENING INTERFACE.

  Patient problems: Insufficient Information

  MAUDE report 21035251 ↗
• InjuryAug 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF THE FEMUR AND TIBIA AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH CHRONIC PAIN. UPON INTRAOPERATIVE EXAMINATION, ALL COMPONENTS WERE FOUND TO BE LOOSE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 20066059 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: "INSTABILITY."

  Patient problems: Joint Laxity

  MAUDE report 18980262 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS . CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: ON (B)(6) 2013. DATE OF REVISION #1: ON (B)(6) 2018. DATE OF REVISION #2: UNK 2023 (LEFT KNEE) TREATMENT: FEMORAL, TIBIAL, INSERT AND PATELLA WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 18463796 ↗
• InjuryNov 20, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF TIBIAL COMPONENT AT UNKNOWN INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2018. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 18174066 ↗
• InjuryNov 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT IS REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2020. DOR; (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18123276 ↗
• InjuryOct 16, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO LOOSENING OF FEMORAL AND TIBIAL COMPONENTS. CEMENT MANUFACTURER IS DEPUY. DOI: ON (B)(6) 2011, DOR: ON (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 17944337 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO MULTIPLE INFECTIONS SINCE THE ORIGINAL TKA WAS DONE. EXPLANTED AND A CEMENT SPACER WAS PUT IN. NO SURGICAL DELAY. DOI: (B)(6) 2013; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17807557 ↗
• InjurySep 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SUSPECTED FAILED SUPPRESSION; DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. DATE OF IMPLANT: (B)(6) 2013. DATE OF REVISION #1: (B)(6) 2018. DATE OF REVISION #2: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 17711350 ↗
• 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 17703405 ↗
• InjuryJul 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS WERE RECEIVED: DOI: (B)(6) 2014: PATIENT RECEIVED BILATERAL SIGMA TKAS TO TREAT OSTEOARTHRITIS. BILATERAL PATELLAS WERE RESURFACED AND UNKNOWN CEMENT WAS UTILIZED. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. DOE: (B)(6) 2023: PATIENT PRESENTS TO CLINIC WITH EFFUSION, PAIN, GRINDING SENSATIONS, WALKING DIFFICULTY, AND CREPITUS OF THE LEFT KNEE. PHYSICAL EXAM IDENTIFIES 1 MM LAXITY AND CONFIRMS WALKING DIFFICULTY, EFFUSION, AND SYNOVITIS. X-RAYS IDENTIFY A STABLE KNEE WITH A VERY THIN LUCENCY UNDER THE ANTERIOR FLANGE. THE PATIENT IS REFERRED FOR EXPLORATORY SURGERY TO IDENTIFY THE SOURCE OF THE SYNOVITIS AND CREPITUS. THERE WERE NO INDICATIONS THAT THE PROCEDURE HAS BEEN COMPLETED.

  Patient problems: Ambulation or Postural Difficulties; Joint Laxity; Pain; Swelling/ Edema; Synovitis; Unspecified Musculoskeletal problem

  MAUDE report 17351138 ↗
• InjuryJun 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR RECURRENT HEMARTHROSIS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2014. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; REVISED COMPONENTS NOT SPECIFIED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17154392 ↗
• InjuryMay 26, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO INCREASING PAIN & DEFORMITY OVER TIME. TIBIAL REVISION WAS PERFORMED. THERE WAS INDICATED LOOSENING OF TIBIAL TRAY AT CEMENT TO IMPLANT INTERFACE. THERE IS NO SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain; Physical Asymmetry

  MAUDE report 17010123 ↗
• InjuryMay 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY LOOSENING OF FEMUR OR TIBIA AT CEMENT TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. DOI: (B)(6) 2007; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 16930017 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR KNEE PAIN. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020 DATE OF REVISION: (B)(6) 2021 DATE OF EVENT: (B)(6) 2023 (LEFT KNEE) TREATMENT: SYNVASURE AND LAB TESTS NEGATIVE FOR INFECTION.

  Patient problems: Pain

  MAUDE report 16852515 ↗
• InjuryApr 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTES INDICATE THAT ON (B)(6) 2023 THE PATIENT HAD A LEFT KNEE ASPIRATION: MEDICAL RECORDS REPORT THAT INFLAMMATION MARKERS WERE SLIGHTLY ELEVATED WITH A SEDIMENTATION RATE OF 43 AND C-REACTIVE PROTEIN IS 28. THE PATIENT¿S LEG IS NOTED TO BE SWOLLEN AND THE PATIENT REPORTS HAVING PAIN. THERE IS MODERATE EFFUSION. THE PATIENT REPORTED THAT THEY HAD A TRAUMA WHERE THEY WERE HANGING FROM HIS KNEE FOR AN HOUR, SO THE SWELLING COULD BE HEMARTHROSIS AND SECONDARY SYNOVITIS. THE PATIENT IS ON ANTIBIOTICS AND AN ASPIRATION WAS ORDERED. ON (B)(6) 2023, MEDICAL RECORDS NOTE THE PATIENT¿S KNEE IS INFECTED WITH STAPH. THE SURGEON IS PLANNING ON DOING A POLY SWAP WITH IRRIGATION. THE CLINICAL DATABASE INDICATES A REVISION OF THE LEFT KNEE WAS COMPLETED ON (B)(6) 2023 AS A TREATMENT FOR INFECTION. THE INSERT WAS REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16742569 ↗