SIGMA LCS COMPLETE POROCOATRecalls & reported problems across all models
Depuy (Ireland) · 11 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 77
- Deaths reported
- 0
- Injuries reported
- 74
- Recalls
- 0
We found 11 models of SIGMA LCS COMPLETE POROCOAT by Depuy (Ireland) in the FDA's device registry (GUDID). Together they are named in 77 adverse event reports in the FDA's MAUDE database, received between Aug 18, 2017 and Aug 27, 2026 — classified as 74 injuries, 3 malfunctions.
The most frequently reported specific device problem is “Osseointegration Problem” (12 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SIGMA LCS COMPLETE POROCOAT problems
Device problems
- Adverse Event Without Identified Device or Use Problem34
- Osseointegration Problem12
- Loss of Osseointegration10
- Insufficient Device Problem Information5
- Loss of or Failure to Bond5
- Migration3
- Appropriate Device Problem Term/Code Not Available2
- Device Disinfection Or Sterilization Issue1
Patient problems
- Pain34
- No Code Available20
- Inadequate Osseointegration19
- Unspecified Infection15
- Muscular Rigidity5
- Bone Fracture(s)4
- Joint Laxity4
- Swelling/ Edema4
SIGMA LCS COMPLETE POROCOAT models
11 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SIGMA LCS COMPLETE POROCOAT 1294-32-130Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing17 reports
- SIGMA LCS COMPLETE POROCOAT 1294-32-140Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing15 reports
- SIGMA LCS COMPLETE POROCOAT 1294-34-130Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing11 reports
- SIGMA LCS COMPLETE POROCOAT 1294-32-150Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing8 reports
- SIGMA LCS COMPLETE POROCOAT 1294-34-140Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing8 reports
- SIGMA LCS COMPLETE POROCOAT 1294-32-125Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing4 reports
- SIGMA LCS COMPLETE POROCOAT 1294-34-125Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing4 reports
- SIGMA LCS COMPLETE POROCOAT 1294-34-150Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing4 reports
- SIGMA LCS COMPLETE POROCOAT 1294-32-120Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing3 reports
- SIGMA LCS COMPLETE POROCOAT 1294-34-120Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing2 reports
- SIGMA LCS COMPLETE POROCOAT 1294-32-160Prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing1 report
Recent SIGMA LCS COMPLETE POROCOAT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 27, 2026Osseointegration Problem
It was reported that original surgery date was unknown. Patient needed complete revision for tibial bone loss. Multiple large cysts had developed and tibial component was loose. Further bone loss was experienced during the removal process. Attune revision components implanted without issue. Loosening was at the bone to implant (Non-Cemented) interface.Affected Side: Left Knee.
Patient problems: Bone Notching; Cyst(s); Inadequate Osseointegration; Pain
MAUDE report 50476589 ↗InjuryDec 4, 2025Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PATIENT UNDERWENT THE REVISION OF LCS DUE TO BEARING WEARING OUT PARTICULARLY ON THE MEDIAL SIDE. THIS HAS BEEN IMPLANTED INSITU FOR A SIGNIFICANT AMOUNT OF TIME. PATIENT UNDERWENT A REVISION FROM LCS TO ATTUNE REVISION USING A STEM AND SLEEVE ON THE FEMUR & TIBIA. SURGERY WAS SUCCESSFUL AND SURGEON WAS HAPPY WITH THE BALANCE AT THE END OF THE CASE.
Patient problems: Insufficient Information
MAUDE report 23720880 ↗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 ↗InjuryAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTED LEFT TKR THAT REQUIRED REMOVAL OF INFECTED IMPLANTS FOR FIRST STAGE REVISION. PATIENT HAD A WASHOUT AND POLY INSERT EXCHANGE DONE.
Patient problems: Unspecified Infection
MAUDE report 22849875 ↗InjuryMay 7, 2025Osseointegration Problem; Osseointegration Problem
(B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION DUE TO FEMORAL (IMPLANT TO BONE) AND TIBIAL LOOSENING (IMPLANT TO BONE). AT REMOVAL THE TIBIAL INSERT SHOWED MINOR YELLOWING.
Patient problems: Insufficient Information
MAUDE report 21979294 ↗InjuryNov 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
SUBJECT ID: (B)(4). STUDY NO: DOTS. CLINICAL ADVERSE EVENT RECEIVED FOR SYNOVIAL PINCH VS INFECTION / HEMARTHROSIS DEVICE RELATEDNESS: POSSIBLY. PROCEDURE RELATEDNESS: DEFINITELY NOT. DATE OF EVENT: 14/NOV/2024. DATE OF IMPLANT: NO INFORMATION PROVIDED. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: RIGHT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.
Patient problems: Ambulation or Postural Difficulties; Hemorrhage/Blood Loss/Bleeding; Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 20777605 ↗InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT HAD A REVISION DONE FOR FLEXION INSTABILITY. UNFORTUNATELY NO IMPLANT RECORD WAS AVAILABLE. SOME OF THE IMPLANTS HAD LEGIBLE IMPLANT, BUT OTHERS WERE NOT. THE METAL BACKED PATELLA WAS REPLACED WITH A NEW POLY. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT KNEE.
Patient problems: Joint Laxity
MAUDE report 20312065 ↗InjurySep 23, 2024Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem; Loss of or Failure to Bond; Adverse Event Without Identified Device or Use Problem
PATIENT HAS HAD A KNEE REPLACEMENT- ON- (B)(6) 2021. STARTED HAVING ISSUES UNABLE TO DO PHYSICAL THERAPY DUE TO EXTREME PAIN. WENT 9 MONTHS UNTIL HE HAD AN ADDITIONAL SURGERY. . HE HAD TO HAVE A SECOND SURGERY ON THIS SAME KNEE AND TOLD HIM THAT A PIECE FELL APART. HE WANTS TO LET SOMEONE KNOW THAT HIS FIRST KNEE REPLACEMENT WAS A FAILURE. ADDITIONAL INFORMATION RECEIVED DATED SEP 16, 2024: ON (B)(6) 2021, THE PATIENT HAD A RIGHT TOTAL KNEE ARTHROPLASTY. THE PATIENT WAS REVISED ON (B)(6) 2023 TO ADDRESS PAIN AND LIMITED MOBILITY AS WELL AS POSSIBLE INFECTION. PATIENT STATED THAT ONE OF THE PIECES "BROKE OFF", BUT WAS NOT CERTAIN WHICH PIECE BROKE. DEPUY COMPONENTS WERE REMOVED AND DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI: (B)(6) 2021. DOR: (B)(6) 2023. RIGHT KNEE.
Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Joint Contracture; Loss of Range of Motion; Pain; Swelling/ Edema; Unspecified Infection; Unspecified Tissue Injury
MAUDE report 20279528 ↗InjuryMay 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT KNEE.
Patient problems: Pain
MAUDE report 19343315 ↗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 ↗InjuryNov 9, 2023Migration; Migration
LITIGATION COMPLAINT RECEIVED 24 OCT 2023 WAS REVIEWED BY CLINICIAN. ON (B)(6) 2002, THE PATIENT HAD A LEFT NON-CEMENTED LCS TOTAL KNEE ARTHROPLASTY, TO ADDRESS LEFT KNEE MEDIAL FEMORAL CONDYLE CHONDRAL DEFECT WITH THE PATELLOFEMORAL CHONDRAL DEFECT. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2023 THE PATIENT HAD A LEFT TOTAL KNEE REVISION TO ADDRESS ARTHROPLASTY MECHANICAL FAILURE. THE SURGICAL FINDINGS INCLUDED TIBIAL SUBSIDENCE WITHOUT LOOSENING, AND PATELLAR BUTTON POLY WEAR. THE TIBIA WAS NOTED TO HAVE SUBSIDED 10MM. COMPETITOR COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. DOI:(B)(6) 2002. DOR:(B)(6) 2023 (LEFT KNEE).
Patient problems: Joint Laxity; Pain; Unspecified Tissue Injury
MAUDE report 18101182 ↗InjuryOct 19, 2023Osseointegration Problem; Osseointegration Problem
PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE FEMUR AND TIBIA AT BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS DEPUY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.
Patient problems: Inadequate Osseointegration; Pain
MAUDE report 17967535 ↗InjuryJun 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION AND SEVERE PAIN. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS NOT RELATED TO EITHER DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2018. DATE OF REVISION: UNK. DATE OF EVENT: (B)(6) 2023. (LEFT KNEE). TREATMENT: REVISION; FEMORAL COMPONENT, TIBIAL BASE, AND PATELLA WERE REMOVED.
Patient problems: Pain; Unspecified Infection
MAUDE report 17216879 ↗
Other Depuy (Ireland) products
All Depuy (Ireland) devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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