LCS SIGMA 1294-33-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 207 adverse event reports that list this exact device (DI 10603295025771), received between Jun 22, 2017 and Mar 30, 2026 — classified as 206 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (126 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 207 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 24735199 ↗
• InjuryJan 15, 2026Loss of or Failure to Bond; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LIGAMENTOUS INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 24085083 ↗
• InjuryJan 15, 2026Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE ARE NO ADVERSE EFFECTS.

  Patient problems: Joint Laxity

  MAUDE report 24079851 ↗
• InjuryDec 8, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION FOR LOOSE IMPLANTS. DATE OF ORIGINAL SURGERY IS UNKNOWN. LOT NUMBER ON IMPLANT ARE NOT VISIBLE. PRODUCTS STATED TO BE LOOSE: TIBIA AND PATELLA. LOOSENING INTERFACE: CEMENT TO IMPLANT. CEMENT MANUFACTURER: UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23750667 ↗
• InjuryNov 5, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q3 OF 2025. (B)(6) 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 INSTABILITY AND PAIN.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23478993 ↗
• InjuryOct 15, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT TIBIAL HAS COLLAPSED MEDIALLY, CAUSING THE IMPLANT TO BE MISALIGNED AND LOOSE. THERE WAS LOOSENING OF THE TIBIAL TRAY AT CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 23300423 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELL AND WAS HAVING KNEE PAIN. DATE OF ORIGINAL SURGERY WAS UNKNOWN. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Fall; Pain

  MAUDE report 22384619 ↗
• InjuryJun 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 22350598 ↗
• InjuryFeb 20, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT PATIENT HAD CATASTROPHIC FAILURE OF THE TIBIA WITH SIGNIFICANT LOOSENING. NO TRAUMATIC EXPERIENCE HAD OCCURRED PRIOR TO THIS. LOOSENING OCCURRED AT CEMENT/IMPLANT INTERFACE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21425861 ↗
• InjuryFeb 10, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THIS PATIENT'S KNEE WAS REVISED DUE TO SUSPECTED FEMORAL AND POSSIBLY TIBIAL COMPONENT LOOSENING AT CEMENT TO IMPLANT INTERFACE. THE PATIENT'S PRIMARY SIGMA COMPONENTS (INSERT, TIBIAL TRAY, AND FEMUR) WERE REMOVED AND REPLACED BY ATTUNE REVISION COMPONENTS. AFFECTED SIDE : LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21342975 ↗
• InjuryDec 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q4 OF 2024. (B)(6) 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 TIBIA (UNKNOWN INTERFACE), OSTEOLYSIS BEHIND FEMUR, PAIN, AND VARUS DEFORMITY.

  Patient problems: Pain

  MAUDE report 21028007 ↗
• InjuryDec 27, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING OF FEMUR AND TIBIA AT CEMENT TO IMPLANT INTERFACE. SURGICAL DELAY UNKNOWN. FEMUR AND TIBIAL TRAY WERE REVISED TO ADDRESS IMPLANT LOOSENING AT THE CEMENT TO IMPLANT INTERFACE--THE CEMENT MANUFACTURER IS DEPUY. IT IS REASONABLE TO CONCLUDE THAT THE BONE CEMENT, FEMUR AND THE TIBIAL TRAY EACH CAUSED/CONTRIBUTED TO THEIR EVENTS, AS THEIR BONDING INTERFACES ARE PROPERTIES INHERENT TO THE DESIGN AND MANUFACTURE OF EACH DEVICE--NO OTHER KNEE IMPLANTS PLAY ANY ROLE IN MAINTAINING THOSE BONDING INTERFACES. DOI: (B)(6) 2013. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 21026225 ↗
• InjuryDec 2, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO LOOSENING OF FEMUR AND TIBIA AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20820227 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE DEVICE (RELATEDNESS): DEFINITELY NOT, PROCEDURE (RELATEDNESS): POSSIBLY, DATE OF EVENT: 28/AUG/2024, DATE OF IMPLANT: INFORMATION NOT PROVIDED, DATE OF REVISION: INFORMATION NOT PROVIDED, DEVICE LOCATION: INFORMATION NOT PROVIDED. TREATMENT/IMPACT: PE

  Patient problems: Pulmonary Embolism

  MAUDE report 20290345 ↗
• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID:(B)(6). STUDY ID: DOTS. A CLINICAL STUDY REPORTED A CLINICAL ADVERSE EVENT ON AUGUST 28, 2024, FOR A VASCULAR - PULMONARY EMBOLISM (PE). DATE OF IMPLANT IS UNKNOWN.

  Patient problems: Pulmonary Embolism

  MAUDE report 20280858 ↗
• InjuryJul 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT SURGEON IMPLANTED SIGMA KNEE IN 2012. PATIENT HAD A LOOSE TIBIA AND WAS REVISED TO A REVISION TRAY. DOI: 2012. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19772607 ↗
• InjuryJun 27, 2024Migration; Migration

  IT WAS REPORTED THAT THE TIBIAL TRAY SUBSIDED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19624437 ↗
• InjuryJun 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT FELL IN 2022 AND SUFFERED A TIBIAL FRACTURE. THIS APPEARS TO HAVE CAUSED THE TIBIAL PLATEAU TO COLLAPSE OVER TIME. PATIENT REQUIRED A REVISION SURGERY ON (B)(6) 2024 AT HOSPITAL, THE TIBIA CAME OFF RELATIVELY EASILY, WITH NO CEMENT ATTACHED TO THE BOTTOM OF THE TIBIA. THE CEMENT USED IS BELIEVED TO BE A COMPETITOR AT THE TIME. THE FEMUR WAS WELL FIXED, HOWEVER THE FROZEN TISSUE CAME BACK AS INFECTED. SO ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 19556331 ↗
• InjuryJun 3, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING. THERE WAS A LOOSENING REPORTED AT TIBIA IN CEMENT TO IMPLANT INTERFACE. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE : RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19449443 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS . CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: (B)(6) 2024. (RIGHT KNEE). TREATMENT: I&D.

  Patient problems: Unspecified Infection

  MAUDE report 19228717 ↗
• InjuryApr 25, 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: POLY WEAR, PAIN, INSTABILITY.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19181727 ↗
• InjuryApr 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A SIGMA RP CR CONSTRUCT IN 2021. SHE HAS DEVELOPED PAIN OVER THE YEARS SINCE THE KNEE. SHE DEVELOPED POOR PATELLAR TRACKING IN THIS KNEE. A TIBIA TUBERCLE OSTEOTOMY WAS PERFORMED TO HELP WITH PATELLAR TRACKING AND KNEE REVISION WAS PERFORMED. THE FEMUR, INSERT, AND TIBIA WERE ALL REMOVED AND AN ATTUNE CRS REVISION CONSTRUCT WAS PLACED. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19134936 ↗
• InjuryApr 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Laxity

  MAUDE report 19042917 ↗
• InjuryApr 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE TIBIA AND PATELLA WERE REVISED DUE TO FAILURE OF TRAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE : LEFT KNEE. THERE WAS NO SURGICAL DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19013267 ↗
• InjuryMar 26, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: PAIN & LOOSENING.

  Patient problems: Pain

  MAUDE report 18977421 ↗