LCS SIGMA 1294-31-120Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295025580), received between Aug 13, 2018 and Nov 18, 2024 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 18, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND THE SIZE 2 SIGMA RP TIBIAL TRAY WAS REMOVED FOR LOOSENING AND IT WAS REPLACED WITH A SIGMA SZ 2 FIXED BEARING TRAY. THERE WAS TIBIAL LOOSENING AT THE CEMENT/IMPLANT INTERFACE. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 20708306 ↗
• InjurySep 15, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  LCS IMPLANTS REMOVED DUE TO TIBIAL LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 15427726 ↗
• InjuryDec 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED PATELLAR INSTABILITY SINCE ABOUT ONE YEAR WITH EVENTUAL KNEE INSTABILITY IN GENERAL. PAIN BECAME IMMOBILIZING AND PATIENT REPORTED TO PARTNER HOSPITAL (SPITAL AFFOLTERN) AT THE EMERGENCY DEPARTMENT. A SUBLUXATED KNEE PROSTHESIS WAS DIAGNOSED AND RESONATED, THEREAFTER PATIENT WAS REFERRED TO (B)(6). PATIENT REPORTED TO (B)(6) AND WAS WEARING A KNEE BRACE FOR STABILITY. INTRAOPERATIVE KNEE INSTABILITY WAS OBSERVED TOGETHER WITH DISSOCIATING PATELLAR INLAY, WHICH MAY BE EXPLAINED BY REPEATED PATELLAR SUBLUXATIONS AND RESULTING EXCENTRIC LOADS. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN SIDE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 13001211 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY KNEE WAS PLACED IN VARUS AND THE PATIENT WAS UNHAPPY WITH THE RESULT AND COMPLAINED OF INSTABILITY. REVISED TO ATTUNE REVISION.

  Patient problems: Discomfort; No Code Available

  MAUDE report 10362914 ↗
• InjurySep 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS AD 28 AUG 2019 REVIEWED FOR MDR REPORTABILITY. PATIENT UNDERWENT A LEFT TKA WITH SIGMA IMPLANTS ON (B)(6) 2016. THE PATELLA WAS RESURFACED AND DEPUY CEMENT X 2 WAS UTILIZED. THE LEFT KNEE WAS LATER REVISED FOR PAIN AND DYSFUNCTION WITH ADLS ON (B)(6) 2018. ASEPTIC LOOSENING OF THE TIBIAL TRAY AT THE CEMENT TO IMPLANT INTERFACE WAS CONFIRMED DURING THE REVISION. OF NOTE, THE PATIENT HAS ALSO UNDERGONE A RIGHT KNEE TKA IN 2014. AN OFFICE VISIT NOTE FROM (B)(6) 2016 STATES THE PATIENT WAS HAVING PAIN AND LIMITED RANGE OF MOTION IN THE RIGHT KNEE THOUGH THERE IS NO INDICATION OF THE MANUFACTURER OF THESE IMPLANTS AND NO RIGHT REVISION HAS BEEN NOTED.

  Patient problems: No Code Available; Pain

  MAUDE report 9100879 ↗
• InjuryMay 23, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 8636088 ↗
• InjuryOct 10, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 7951283 ↗
• InjuryAug 13, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE TIBIAL TRAY AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER UNKNOWN. IT HAD NO CEMENT ON THE IMPLANT. ALL COMPONENTS WERE REMOVED AND REVISED TO TC3 RP. DOI: UNKNOWN; DOR: (B)(4) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7776547 ↗