LCS SIGMA 1294-31-150Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 10603295025627), received between Mar 21, 2018 and Feb 10, 2024 — classified as 16 injuries.

The most frequently reported specific device problem is “Migration” (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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. E. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR? NO, POLY WEAR WAS NOTED. F. WAS THERE ANY REPORTED MALPOSITION OF COMPONENTS THAT LED TO THE INSTABILITY? NO. G. WERE ANY COMPONENTS UNDERSIZED ON THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. H. WAS THE FEMUR OR TIBIA EXCESSIVELY RESECTED/JOINT LINE RAISED, DURING THE PRIMARY SURGERY THAT LED TO THE INSTABILITY? NO. INSTABILITY WAS, DUE TO INSUFFICIENT SUPPORTING LIGAMENTS. THEREFORE, NEEDED CONSTRAINT FROM SROM NOILES.

  Patient problems: Joint Laxity

  MAUDE report 18682694 ↗
• InjuryDec 22, 2023Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  REVISION LEFT KNEE. PRIMARY IMPLANTS - RIGHT LCS FEMUR, 12.5MM INSERT AND SIZE 5 TIBIA. REVISION FOR SUBSIDENCE AND LOOSENING OF COMPONENTS. FEMUR REMOVED BY HAND - CLEAN (CEMENT LEFT ON BONE - NO CEMENT DETAILS AVAILABLE). TIBIA REMOVED VERY EASILY AS WELL WITH CEMENT ALL ATTACHED TO BONE AND NOT IMPLANT. DARK METALLOSIS APPEARED ON KNEE TISSUE, NO SIGNS OF INFECTION. SURGEON WASHED, DEBRIDED THEN REVISED USING ATTUNE REVISION.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 18383111 ↗
• InjurySep 9, 2022Migration; Migration

  PATIENT WAS REVISED DUE TO TIBIAL SUBSIDENCE. THE CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2019, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 15391995 ↗
• InjuryAug 29, 2022Loss of or Failure to Bond; Use of Device Problem; Migration; Loss of or Failure to Bond; Use of Device Problem; Migration

  SPOKE WITH PATIENT ON PHONE TODAY (B)(6) 2022. PATIENT STATES HIS PRIMARY WAS DONE IN (B)(6), ON (B)(6) WITH DEPUY IMPLANTS. HE HAS NOW HAD A REVISION ON (B)(6) 2022. HE STATES THE TRAY WAS TILTED AND PRIOR TO THE REVISION, HE HAD PAIN AND DIFFICULTY WALKING. PART/LOT PROVIDED OF THE FEMORAL AND INSERT ARE BELOW. HE DID NOT HAVE ANY INFORMATION REGARDING THE TRAY. HE THEN REQUESTED COMPENSATION AND HIS INFORMATION HAS BEEN FORWARDED TO LEGAL (SEE (B)(4) LEGAL NOTIFICATION). HE WAS ALSO PROVIDED THE CONTACT INFORMATION OF THE LEGAL PARALEGAL. HE HAS NO FURTHER NEEDS AT THIS TIME. DOI: (B)(6) 2019; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Bone Fracture(s); Fatigue; Pain; Rash; Swelling/ Edema; Synovitis; Unspecified Infection

  MAUDE report 15311858 ↗
• InjuryMay 20, 2022Migration; Migration

  PRIMARY CR150 MBT TKJA IN SITU - IMPLANTED (B)(6) 2017, PATIENTS HAS CONSISTENTLY COMPLAINED ABOUT PAIN AND INSTABILITY. ON X-RAY - IMPLANTS APPEAR WELL FIXED WITH SOME FOREIGN LOOSE BODIES NOTED POSTERIOR KNEE AND NATIVE PATELLA - FEMUR AND TIBIA APPEAR IN VARUS POSITION AND FEMUR HAS FLEXED. PLAN WAS TO OPEN AND REMOVE LOOSE BODIES AND RESURFACE PATELLA WITH ? FULL ATTUNE REVISION PRIMARY IMPLANTS EXPLANTED AND FULL ATTUNE REVISION PERFORMED. FEMUR - SIZE 8 RIGHT WITH 18X60MM PRESSFIT STEM AND 40MM PARTIALLY COATED SLEEVE. 4MM DISTAL AUGMENTS MEDIALLY AND LATERALLY. TIBIA - SIZE 7 REVISION RP BASE WITH 14X60MM PRESSFIT STEM, 37MM PARTIALLY COATED SLEEVE POLY - 8/10MM REVISION INSERT.

  Patient problems: Bone Fracture(s); Joint Laxity; Pain

  MAUDE report 14462539 ↗
• InjurySep 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. UNKNOWN BONE CEMENT WAS USED. OSTEOLYSIS WAS ALSO NOTED. DOI: 2000, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12485953 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  RIGHT TOTAL KNEE WAS REVISED DUE TO PAIN. ORIGINAL DOS 2007. IMPLANT LOT NUMBERS ARE NOT AVAILABLE. NO OTHER PATIENT INFORMATION AVAILABLE. NO REPORTED SURGICAL DELAYS. UNKNOWN CEMENT WAS UTILIZED.

  Patient problems: Pain

  MAUDE report 11873923 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CR150 LEFT KNEE REPLACEMENT REQUIRES REVISION DUE TO INSTABILITY IN BOTH FLEXION AND EXTENSION. PRIMARY PROCEDURE DATE: (B)(6) 2019.

  Patient problems: Joint Laxity

  MAUDE report 10889352 ↗
• InjuryOct 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF AN LCS LRG, LRG INLAY 10MM AND TIBIA SIZE 5, AND FEMORAL COMPONENT. PATIENT RECEIVED AN WC SIZE 5, 15X30 STEM, TIBIA SIZE 4, 13X30 MM AND INLAY 15MM. PLEASE NOTE THAT DURING REMOVAL THE CONE FROM THE INLAY WAS KNOCKED OFF. THE PATIENT WAS REVISED FOR PROGRESSIVE INSTABILITY. THE FEMORAL COMPONENT, TIBIAL TRAY, AND INSERT WERE REVISED

  Patient problems: No Code Available

  MAUDE report 10734822 ↗
• InjuryMar 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS IMPLANTED IN 2011 BY (B)(6). PATIENT REPORTED PAIN AND DIFFICULTY MOBILISING, X-RAY REVEALED TIBIAL PERI-PROSTHETIC FRACTURE & OSTEOLYSIS ON THE LATERAL FEMORAL CONDYLE. ON REMOVAL OF THE IMPLANTS, MARKED DELAMINATION AND A LARGE CRACK ON THE MEDIAL SIDE OF THE POLYETHYLENE. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)?--> PAIN, INFLAMMATION, DECREASED PHYSICAL FUNCTION, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> YES, IF YES, DESCRIBE --> X-RAY, IS THE PATIENT PART OF A CLINICAL STUDY --> NO, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE, (B)(4). DEVICE PROPERTY OF -->NONE, DEVICE IN POSSESSION OF -->NONE. BY CHECKING THIS BOX I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED. IF ANY NEW INFORMATION WILL BE MADE AVAILABLE, THE ADDITIONAL INFORMATION WILL BE SUBMITTED THROUGH CST.--> TRUE.

  Patient problems: Bone Fracture(s); Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9871523 ↗
• InjuryFeb 19, 2020Unintended Movement; Migration; Unintended Movement; Migration

  PATIENT WAS REVISED DUE TO LEFT TIBIA FRACTURE AND SUBSIDENCE. LG 10 MM POLY LCS COMPLETE, SZ 5 TIBIA NON KEELED MBT WERE EXPLANTED. LOT NUMBERS COULD NOT BE READ. DOI: UNKNOWN; DOR: (B)(6) 2020 LEFT KNEE.

  Patient problems: Bone Fracture(s); No Code Available

  MAUDE report 9728816 ↗
• InjuryAug 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAS BEEN COMPLAINING OF "STIFFNESS AND LOSS OF FUNCTION" OVER THE LAST 6 TO 8 MONTHS. FOLLOWING INVESTIGATIONS, BLOODS AND SCANS DIDN'T SEEM TO INDICATE INFECTION, BUT COMPONENTS WERE SUSPECTED TO BE LOOSE. REVISION SURGERY WAS PERFORMED, AND BOTH FEMUR AND TIBIA WERE LOOSE (FAILURE WAS A COMBINATION OF IMPLANT/CEMENT AND CEMENT/BONE INTERFACES - PALACOS BONE CEMENT WAS USED IN THE ORIGINAL CASE). KNEE WAS REVISED TO AN ATTUNE REVISION KNEE SYSTEM. PATIENT STATUS/ OUTCOME/ CONSEQUENCES: YES.

  Patient problems: Joint Disorder; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8910893 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8639943 ↗
• InjuryFeb 6, 2019Loss of or Failure to Bond; Migration; Loss of or Failure to Bond; Migration

  PATIENT HAD TOTAL KNEE REVISION FOR LOOSE, SUBSIDED TIBIAL COMPONENT. AFTER DETERMINING THERE WAS NO INFECTION PRESENT, ALL ORIGINAL COMPONENTS EXCEPT PATELLA WERE REMOVED & REVISION WAS COMPLETED. FEMORAL & TIBIAL COMPONENT WERE LOOSE AT CEMENT TO IMPLANT INTERFACE. THERE WAS SMALL INSTRUMENT DELAY DURING CASE IN WHICH THE ATTUNE FEMORAL BROACH TRIAL BOLT ENDED UP WITH STRIPPED THREADS WHICH WOULD ALLOW CONNECTION BETWEEN FEMORAL TRIAL & SLEEVE TRIAL. SURGERY CONTINUED ONCE BOLT WAS SWITCHED OUT.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 8309838 ↗
• InjuryNov 28, 2018Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available; Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Pain

  MAUDE report 8110876 ↗
• InjuryMar 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE, CEMENT MANUFACTURER IS UNKNOWN. LCS KNEE WAS REVISED. DOI: UNKNOWN; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 7357535 ↗