LCS SIGMA 1294-33-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295025818), received between Dec 22, 2017 and Dec 18, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO SUBSIDED LOOSENING OF TIBIAL COMPONENT. THE PATIENT EXPERIENCED PAIN AND INSTABILITY. LOOSENING INTERFACE WAS MARKED AS CEMENT TO IMPLANT. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 23837662 ↗
• InjuryOct 25, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED PATIENT'S RIGHT KNEE WAS REVISED ON (B)(6) 2024 DUE TO ASEPTIC TIBIAL AND FEMORAL LOOSENING. FEMORAL COMPONENT LOOSENED AT THE CEMENT TO BONE INTERFACE. TIBIA LOOSENED AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS DEPUY SYNTHES. THE TIBIA TRAY CAME OUT CLEAN UNDERNEATH. PATELLA BUTTON HAD A GASH ON THE POLY SO IT WAS ALSO REVISED. DATE OF INITIAL IMPLANT WAS (B)(6) 2011.

  Patient problems: Insufficient Information

  MAUDE report 20533653 ↗
• InjuryJun 28, 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: (B)(6) 202. DATE OF REVISION: (B)(6) 2024. (RIGHT KNEE). TREATMENT: FEMORAL COMPONENT, TIBIAL, AND INSERT WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19632750 ↗
• InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR CHRONIC INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2024. DATE OF EVENT: 02 APR 2024. (RIGHT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL, INSERT, AND PATELLA WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 19164081 ↗
• InjuryMar 22, 2024Loss of or Failure to Bond; Use of Device Problem; Loss of or Failure to Bond; Use of Device Problem

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

  Patient problems: Pain

  MAUDE report 18959610 ↗
• InjuryJul 31, 2020Migration; Migration

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE CEMENT USED WAS UNKNOWN.

  Patient problems: No Code Available; Pain

  MAUDE report 10350176 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR GLOBAL INSTABILITY. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS DEFINITELY RELATED TO DEVICE AND IS PROBABLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019. DATE OF REVISION: (B)(6) 2019. DATE OF EVENT (ONSET): (B)(6) 2019. (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9311282 ↗
• InjurySep 10, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED DUE TO SEPTIC LOOSENING AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. THE PATIENT HAD MET THE MSIS CRITERIA FOR SEPSIS. THE INITIAL SURGERY WAS ON (B)(6) 2015. COMPETITOR BONE CEMENT WAS USED. NO ACCESS TO BE ABLE TO CONFIRM INFECTION. DOI: (B)(6) 2015, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8983111 ↗
• InjuryDec 26, 2018Migration; Migration

  THE PATIENT WAS REVISED DUE TO FALL, CAUSING THE TIBIA TO SUBSIDE ON THE MEDIAL SIDE. A BIGGER INSERT WAS PLACED. DOI: (B)(6), 2011; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8196732 ↗
• InjuryJul 26, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AND PATELLA COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2012; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7721865 ↗
• InjuryDec 22, 2017Loss of or Failure to Bond; Loose or Intermittent Connection; Insufficient Device Problem Information; Loss of or Failure to Bond; Loose or Intermittent Connection; Insufficient Device Problem Information

  LITIGATION RECORD RECEIVED. LITIGATION ALLEGES PAIN, INJURY, SWELLING, STIFFNESS, WEAKNESS, DISCOMFORT, EMOTIONAL DISTRESS AND EFFUSION IN THE LEFT KNEE WITH DOCUMENTED INFECTION. IT WAS ALSO CONFIRMED THAT THE INDICATION FOR SURGERY WAS "THE LEFT TKR WITH ASEPTIC LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS."

  Patient problems: Discomfort; Distress; Injury; Joint Disorder; Loss of Range of Motion; Muscular Rigidity; No Code Available; Pain; Swelling; Unspecified Infection; Weakness

  MAUDE report 7141809 ↗