SIGMA LCS COMPLETE POROCOAT 1294-32-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295025702), received between Oct 6, 2017 and Oct 30, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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.

• InjuryOct 30, 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 INFECTED KNEE. IMPLANTS WERE REMOVED AND CEMENT SPACER WAS IMPLANTED. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 23424220 ↗
• InjuryMay 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR POSSIBLE INFECTION. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (LEFT KNEE) TREATMENT: ASPIRATION/DRAINAGE.

  Patient problems: Unspecified Infection

  MAUDE report 19232048 ↗
• InjuryFeb 15, 2024Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED PATIENT WAS REVISED DUE TO LOOSE TIBIA. DID THE EVENT OCCUR DURING STERILE PROCESSING? --> NO. DID THE EVENT OCCUR DURING FIELD INSPECTION? --> NO. DID THE EVENT OCCUR DURING INTERNAL SERVICE ACTIVITIES SUCH AS CALIBRATION? --> NO. PATIENT STATUS/ OUTCOME / CONSEQUENCES --> NO. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: --> UNKNOWN. IS THE PATIENT PART OF A CLINICAL STUDY --> UNKNOWN. (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: Inadequate Osseointegration

  MAUDE report 18715164 ↗
• InjuryJan 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2005. DOR: (B)(6) 2024. RIGHT KNEE. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES. PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? INFECTION. WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED? YES. IF YES, DESCRIBE: REVISION SURGERY. IS THE PATIENT PART OF A CLINICAL STUDY? UNKNOWN. (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: Unspecified Infection

  MAUDE report 18453070 ↗
• InjuryJul 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF A LCS KNEE IMPLANT DUE TO PAIN. DOI: UNK. DOR: (B)(6) 2022. UNKNOWN KNEE.

  Patient problems: Pain

  MAUDE report 15013836 ↗
• InjuryFeb 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR PERSISTENT DISCOMFORT IN BOTH KNEES. POSTERIOR STIFFNESS AND PAIN. PAIN IS BILATERAL BUT WORSE IN THE LEFT. EVENT IS NOT SERIOUS AND IS CONSIDERED MODERATE. THERE IS A REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020, DATE OF EVENT (ONSET): (B)(6) 2021, (LEFT KNEE). TREATMENT: LEFT KNEE WAS ASPIRATED AND SENT FOR SYNVASURE TO RULE OUT INFECTION. NO ARTHROFIBROSIS NOTED. LEFT KNEE IS STABLE. NO TREATMENT REPORTED FOR THE RIGHT SIDE.

  Patient problems: Discomfort; Muscular Rigidity; Pain

  MAUDE report 11334312 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2020. DATE OF EVENT (ONSET): (B)(6) 2020. (LEFT KNEE). TREATMENT: ELIQUIS, AFTER SOME COUMADIN AND LOVENOX.

  Patient problems: Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 11087154 ↗
• InjurySep 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE AFFECTED SIDE IS THE LEFT.

  Patient problems: No Code Available

  MAUDE report 10549198 ↗
• InjuryJan 27, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR POSTERIOR PROXIMAL TIBIAL FRACTURE, NO SUBSIDENCE : BONE FRACTURE - TIBIA EVENT IS NOT SERIOUS AND IS CONSIDERED MILD. EVENT IS PROBABLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2019; DATE OF EVENT (ONSET): (B)(6) 2019; (LEFT KNEE).

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

  MAUDE report 9632740 ↗
• InjuryJan 13, 2020Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSE PRESSFIT TIBIAL TRAY. MBT TRAY, SLEEVE AND STEM WAS USED TO GAIN STABILITY. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 9582923 ↗
• InjuryNov 22, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT MANUFACTURER WAS USED. UPON REVIEW OF X-RAYS DOCTOR DETERMINED THAT THE FEMORAL AND TIBIAL COMPONENTS LOOKED LOOSE. DOI: UNKNOWN, DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9364984 ↗
• InjuryAug 30, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8951792 ↗
• InjurySep 19, 2018Migration; Migration

  IT WAS REPORTED THAT THE TIBIAL COMPONENT SUBSIDED AND DECIDED HE NEEDED A PS FOR MORE STABILITY. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable

  MAUDE report 7888993 ↗
• InjuryApr 20, 2018Failure To Adhere Or Bond; Failure To Adhere Or Bond

  THE PATIENT WAS REVISED TO ADDRESS SUBSIDENCE AND LOOSENING OF THE TIBIA AT THE CEMENT TO IMPLANT INTERFACE, DEPUY CEMENT WAS USED. DOI: (B)(6) 2012; DOR: (B)(6) 2018; LEFT KNEE. NO SURGICAL DELAY.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7448363 ↗
• InjuryOct 6, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: CHANGE OF LCS CEMENTLESS TIBIA BECAUSE PATIENT IS SUFFERING FROM GOUT. INTRAOPERATIVELY IT HAD BEEN NECESSARY TO ALSO REVISE FEMUR BECAUSE AS THERE WAS VERY CONSTRICTIVE SPACE. SURGEON IS WONDERING WHETHER THERE WAS BONE INGROWTH AT TIBIAL AND FEMORAL COMPONENT AND ASKS US TO INVESTIGATE ON THIS. UPDATE SEP 7, 2017: TRANSLATED MEDICAL RECORDS REVIEWED. PRIMARY PROCEDURE NOTES (B)(6) 2016 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO LATERALLY PRONOUNCED OSTEOARTHRITIS OF THE ENTIRE LEFT KNEE WITH CHONDROMALACIA. PROCEDURE COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. OFFICE NOTES (B)(6) 2017 INDICATE A BONE SCAN WAS PERFORMED. FINDINGS INCLUDE PERSISTENT SYNOVIAL HYPEREMIA IN THE LEFT KNEE JOINT, CONSISTENT WITH SYNOVITIS. NO EVIDENCE OF LOOSENING OF THE TOTAL KNEE REPLACEMENT. IT IS ALSO INDICATED WITHIN THIS NOTE THAT THE PATIENT RECEIVED RADIOSYNOVIORTHESIS ON (B)(6) 2016. IT WAS RECOMMENDED THAT HE BE TREATED WITH THIS AGAIN DUE TO THE CONTINUING SYNOVITIS. OFFICE NOTES (B)(6) 2017 INDICATE A BONE SCAN WAS PERFORMED. FINDINGS INCLUDE PERSISTENT SYNOVITIS IN THE LEFT KNEE JOINT. THE INCREASE IN BONE METABOLISM AT THE TIB

  Patient problems: Adhesion(s); Joint Disorder; Joint Swelling; Pain; Synovitis; Tissue Damage

  MAUDE report 6925934 ↗