LCS SIGMA 1294-31-125Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295025597), received between Sep 1, 2017 and Dec 15, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (8 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryDec 15, 2025Loss of or Failure to Bond; Loss of or Failure to Bond

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AGE OF THE IMPLANT IS 20 YEARS OLD PROTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 23805054 ↗
• InjuryApr 29, 2024Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO ASEPTIC TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE. SURGEON REMOVED AND NEW MBT REV TRAY W/SLEEVE/STEM & NEW INSERT IMPLANTED. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 19202456 ↗
• InjuryJan 20, 2023Use of Device Problem; Use of Device Problem

  IMPLANT WRONG MA ALIGNMENT. DOI: UNKNOWN, DOR: (B)(6) 2023, UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 16213927 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY TREATING THE KNEE JOINT. ON (B)(6) 2021, BECAUSE OF INFECTION, ALL IMPLANTS WERE REMOVED, AND A CEMENT MOLD WAS INSERTED. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY IN 6 WEEKS. DOI: (B)(6) 2019, DOR: (B)(6) 2021, UNKNOWN SIDE.

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

  MAUDE report 12497080 ↗
• InjuryJun 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND BROKE HER TIBIA SO THE SURGEON TO OUT TIBIAL INSERT AND TIBIA. PLACED IN A REVISION TIBIA, STEM, AND INSERT. DOI: (B)(6) 2020 DOR: (B)(6) 2021 LEFT KNEE.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 12073118 ↗
• InjuryMar 26, 2020Loss 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. CEMENT MANUFACTURER IS UNKNOWN. IT WAS ALSO REPORTED THAT THE SURGEON DECIDED TO REMOVE THE FEMORAL COMPONENT AND PUT A NEW KNEE IN. THE POLY INSERT SHOWED REMARKABLY LITTLE WEAR. THE FEMUR WAS NOT LOOSE AND THE PATELLA SHOWED SOME WEAR SO HE REPLACED IT. LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9883889 ↗
• InjuryMar 2, 2020Migration; Migration

  REVISION RIGHT TKR. PATIENT UNDERWENT RIGHT PFC RP, TOTAL KNEE REPLACEMENT ON (B)(6) 2016. PRESENTED TO SURGEON WITH COMPLAINT OF TIBIAL PAIN AND INSTABILITY. SUSPECTED LOOSE TIBIAL TRAY. UPON OPENING THE KNEE, SURGEON STATED IT APPEARED THE TRAY HAD SUBSIDED ON THE LATERAL SIDE. SURGEON PROCEEDED TO REVISE THE TIBIAL TRAY COMPONENT ONLY TO MBT TRAY WITH TIBIAL SLEEVE AND STEM AND UPSIZED THE INSERT. NO AE REPORTED, NO DELAY .

  Patient problems: No Code Available; Pain

  MAUDE report 9776588 ↗
• InjurySep 23, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS RECEIVED 28 AUG 2019 WERE REVIEWED 16 SEP 2019 FOR MDR REPORTABILITY. ON (B)(6) 2016, THE PATIENT UNDERWENT A RIGHT ARTHROPLASTY DUE TO RIGHT KNEE OSTEOARTHRITIS. A RIGHT HYBRID CEMENTED TOTAL KNEE REPLACEMENT USING DEPUY LCS ROTATING PLATFORM KNEE WITH CEMENTLESS STANDARD FEMORAL COMPONENT WITH CEMENTLESS STANDARD PATELLAR COMPONENT WITH 10 MM ROTATING PLATFORM POLY BEARING WITH CEMENTED SIZE 2.5 TIBIAL COMPONENT. UNKNOWN CEMENT WAS UTILIZED DURING THE PRIMARY OPERATION. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2018, THE PATIENT UNDERWENT A RIGHT KNEE REVISION DUE TO TIBIAL TRAY LOOSENING AT THE CEMENT TO IMPLANT INTERFACE, INSTABILITY, AND PAIN. SURGEON NOTED THE TIBIAL TRAY HAD DEBONDED FROM THE CEMENT AND THE PATIENT¿S FEMORAL BONE WAS ¿QUITE OSTEOPOROTIC¿. ALL COMPONENTS WERE REMOVED. THE SURGEON REPORTED NO INTRAOPERATIVE COMPLICATIONS. ALL COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS REVISION. DOI: (B)(6) 2016. DOR: (B)(6) 2018, (RIGHT KNEE).

  Patient problems: No Code Available; Pain

  MAUDE report 9107232 ↗
• InjuryMar 22, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

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

  Patient problems: No Code Available

  MAUDE report 8443434 ↗
• InjuryFeb 15, 2019Loss 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. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2008; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 8342869 ↗
• InjuryNov 29, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: No Code Available

  MAUDE report 8115796 ↗
• InjuryMay 22, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS KNEE PAIN AND INSTABILITY. SURGEON REMOVED ALL COMPONENTS, LEAVING THE SLEEVE AND STEM IMPLANTED. IMPLANTS WERE CEMENTED IN PLACE AND THE KNEE WAS CLOSED. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7533195 ↗
• InjuryNov 25, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA AT BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN.

  Patient problems: Pain

  MAUDE report 7058089 ↗
• InjuryOct 25, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS INFECTION AND LOOSENING OF THE UNKNOWN COMPONENT AT BONE TO CEMENT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN. THE IMPLANTS WERE LOOSE BECAUSE OF INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 6977793 ↗
• InjurySep 1, 2017Loss of or Failure to Bond; Migration or Expulsion of Device; Loss of or Failure to Bond; Migration or Expulsion of Device

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING. IT WAS ALSO REPORTED THAT THE PATIENT FELL SEVERAL MONTHS AGO WITH THE TIBIAL COMPONENTS HAVE FALLEN INTO THE VARUS. LOOSENING OCCURED AT UNKNOWN INTERFACE.

  Patient problems: Fall; Pain

  MAUDE report 6838272 ↗