LCS COMPLETE POROCOAT 1294-03-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295021698), received between Oct 26, 2017 and Nov 24, 2025 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Disinfection Or Sterilization Issue” (1 report).

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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCHOUTENS C, NOLTE PA, VAN NOORT A. TRAUMATIC ANTERIOR TIBIOFEMORAL DISLOCATION OF MOBILE-BEARING TOTAL KNEE ARTHROPLASTY: TWO CASES. TRAUMA CASE REP. 2025 FEB 17; 56:101144. DOI: 10.1016/J.TCR.2025.101144. PMID: 40083388; PMCID: PMC11904596. OBJECTIVE/METHODS/STUDY DATA: THIS STUDY PRESENTS 2 CASES; CASE 1: A 71-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY DEPARTMENT AFTER A FALL FROM STANCE ONTO THE FLOOR IN THE DOMESTIC SETTING, IN WHICH HYPEREXTENSION OF HER LEFT PROSTHETIC KNEE JOINT HAD PROBABLY OCCURRED. A LCS COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED FIFTEEN YEARS PRIOR FOR SYMPTOMATIC LATERAL OSTEOARTHRITIS. CASE 2: A 73-YEAR-OLD CAUCASIAN WOMAN PRESENTED TO THE EMERGENCY ROOM AFTER SLIPPING ON AN OIL SPILL AND FALLING DIRECTLY ONTO HER LEFT KNEE. SHE WAS IN SEVERE PAIN, COULD NOT BEAR WEIGHT, AND HAD A DEFORMED LEFT KNEE JOINT. A LEFT LSC COMPLETE¿ CEMENTLESS ROTATING PLATFORM TKA HAD BEEN IMPLANTED 8 YEARS PRIOR FOR SYMPTOMATIC OSTEOARTHRITIS IN AN UNCOMPLICATED PROCEDURE. LOT, MODEL AND CATALOG NUMBERS ARE NOT AVAILABLE, BUT THE SUSPECTED DEPUY SYNTHES

  Patient problems: Ambulation or Postural Difficulties; Joint Dislocation; Pain

  MAUDE report 23630347 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD DEBRIDEMENT AND CONTRACTURE RELEASE WHICH INCREASED FLEXION TO 85 DEGREES BUT IT THEN STIFFENED UP AGAIN TO ONLY ABOUT 45 DEGREES OF FLEXION. REVISION OF LCS IMPLANTS WHICH WERE IMPLANTED. REVISION DUE TO STIFFNESS, PARTICULARLY GOING UP AND DOWN STAIRS WHICH WAS DEVELOPED POSTOPERATIVELY. THIS WASN'T AN ISSUE INITIALLY POTS OP BUT DEVELOPED OVER TIME. THE PATIENT HAD DEBRIDEMENT AND CONTRACTURE RELEASE WHICH INCREASED FLEXION TO 85 DEGREES BUT IT THEN STIFFENED UP AGAIN TO ONLY ABOUT 45 DEGREES OF FLEXION. THIS WAS HER RIGHT KNEE, NO ISSUES WITH THE LEFT KNEE WHICH NOTES MENTIONED HAD ALSO HAD A TKA. NO PAIN IN LEFT OR RIGHT KNEE. SIZES IN SITU FROM LCS WERE 2.5 TIBIA, 10MM INSERT AND STANDARD FEMUR. INITIAL NOTES POST OP WERE STABLE AND WELL-BALANCED KNEE BUT LATERAL RETINACULAR STRUCTURES WERE TIGHT. NO WEAR WAS OBSERVED ON THE INSERT. A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI (THIS WAS OVER 45 AND WE WERE INFORMED IT WAS SIMILAR CURRENTLY). FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM (WHICH COULDN'T BE SEEN IN THE X-RAY TAKEN), THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TORNIQUET WAS REMOVED AND THE LEG MOVE

  Patient problems: Loss of Range of Motion; Muscular Rigidity

  MAUDE report 22586148 ↗
• InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS REVISION OF LCS IMPLANTS. REVISION DUE TO STIFFNESS, PARTICULARLY GOING UP AND DOWN STAIRS WHICH WAS DEVELOPED POSTOPERATIVELY. THIS WASN'T AN ISSUE INITIALLY POST OP BUT DEVELOPED OVER TIME. THE PATIENT UNDERWENT DEBRIDEMENT AND CONTRACTURE RELEASE WHICH INCREASED FLEXION TO 85 DEGREES BUT IT THEN STIFFENED UP AGAIN TO ONLY ABOUT 45 DEGREES OF FLEXION. THIS WAS HER RIGHT KNEE, NO ISSUES WITH THE LEFT KNEE WHICH NOTES MENTIONED HAD ALSO HAD A TKA. NO PAIN IN LEFT OR RIGHT KNEE. SIZES IN SITU FROM LCS WERE 2.5 TIBIA, 10MM INSERT AND STANDARD FEMUR. INITIAL NOTES POST OP FROM [YEAR] WERE STABLE AND WELL-BALANCED KNEE BUT LATERAL RETINACULAR STRUCTURES WERE TIGHT. NO WEAR WAS OBSERVED ON THE INSERT. A FRACTURE OCCURRED POST REVISION SURGERY, THIS WAS BELIEVED TO BE CAUSED DUE TO THE HIGH BMI. FRACTURE OCCURRED IN THE FEMUR ABOVE THE STEM (WHICH COULDN'T BE SEEN IN THE X-RAY TAKEN), THIS IS BELIEVED TO HAVE OCCURRED AFTER THE TORNIQUET WAS REMOVED AND THE LEG MOVED POST OP.

  Patient problems: Bone Fracture(s); Muscular Rigidity

  MAUDE report 22529934 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD THEIR LCS PRIMARY IMPLANTED FOR MEDIAL COMPARTMENT ARTHRITIS. INITIAL SURGERY WAS UNEVENTFUL BUT PATIENT UNDERWENT MANIPULATION UNDER ANAESTHESIA 12 WEEKS POST OP WHEN KNEE MOTION THEN INCREASED 73-120 DEGREES. THIS WAS THEN REVISED IN 2021 DUE TO MID FLEXION INSTABILITY. THE REVISION JUST INVOLVED SWAPPING THE POLY TO 5MM THICKER (UP TO 17.5 MM POLY). WITHIN 3 WEEKS AFTER THIS SHE WAS BACK TO NORMAL. PATIENT WAS REVISED AGAIN ON (B)(6) 2025, AS PATIENT WAS EXPERIENCING MORE INSTABILITY WHICH HAS CAUSED PATIENT TO FALL MANY TIMES. PATIENT REACHED A POINT WHERE PATIENT DIDN'T TEND TO FLEX THE RIGHT KNEE AND WALKS WITH A STIFFER KNEE GAIT PRESUMABLY DUE TO THE DEGREE OF INSTABILITY. THERE WERE NO INDICATIONS OF LOOSENING. THIS REPORT CAPTURES SECOND REVISION PROCEDURE PERFORMED ON (B)(6) 2025, DUE TO INSTABILITY WHILE RELATED COMPLAINT (B)(4) CAPTURES THE FIRST REVISION FOR TIBIAL INSERT ONLY WHICH WAS PERFORMED IN 2021.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity

  MAUDE report 21936832 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IMPLANTS REMOVED DUE TO INSTABILITY, TIBIAL TRAY LOOSENING. DOI: (B)(6) 2022, DOR: (B)(4). 2022. RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15232829 ↗
• InjuryDec 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PAIN. SURGERY NECESSARY.

  Patient problems: Pain

  MAUDE report 11003671 ↗
• InjuryMay 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS COMPONENTS DUE TO INSTABILITY AND SUBSIDENCE.

  Patient problems: No Code Available

  MAUDE report 10080237 ↗
• InjuryAug 30, 2018Loss of Osseointegration; Loss of Osseointegration

  REVISION KNEE REPLACEMENT; (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2017. TIBIA STAYED INSITU. FEMUR REMOVED DUE TO AREAS OF LOOSENING OR NON-CONTACT. FEMALE PATIENT ID: (B)(6).

  Patient problems: Inadequate Osseointegration; Not Applicable; Pain

  MAUDE report 7832756 ↗
• InjuryAug 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNK; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7796665 ↗
• InjuryJun 1, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION: DR (B)(6), (B)(6) HOSPITAL (B)(6), (B)(6) 2018. PRIMARY IMPLANT DATE: (B)(6) 2016. PATIENT HAD PAIN AND STIFFNESS POST TKA. BONE SCAN SHOWED INCREASED UPTAKE IN KNEE. SURGEON REVISED FEMORAL IMPLANT AND INSERT. PRODUCT CODE: 129409640 /LOT # 8271658: POLY CHANGE ON PATELLA, METAL BACK STILL IMPLANTED - LOOSE FEMORAL COMPONENT. - LOW GRADE INFECTION - AWAITING RESULTS. FEMALE PATIENT INITIALS (B)(6), AGED (B)(6) YEARS, DOB: (B)(6).

  Patient problems: Not Applicable; Pain; Unspecified Infection

  MAUDE report 7562602 ↗
• MalfunctionJan 30, 2018Device Disinfection Or Sterilization Issue; Device Disinfection Or Sterilization Issue

  CUSTOMER WROTE: "I DID A MICROBIOLOGICAL CHECK-UP ON AN IMPLANT ON (B)(6) 2017 AT 07:30. THE EXAMINATION WAS CARRIED OUT BY FIRST OPENING THE BOX, THEN HAND DISINFECTING OF THE STAFF´S HAND AND THEN TAKING THE SAMPLE. THE RESULT SHOCKS ME, AS THE SAMPLING AEROBIC SPORE FORMERS SHOWS TURF GROWTH 16 - 50 CFU. AS YOU CAN READ IN THE LITERATURE, A DISINFECTION OF THE OUTER PACKAGING IS WITHOUT EFFECT." CUSTOMER IS ASKING FOR A STATEMENT. CUSTOMER DOES NOT REMEMBER REF/LOT; A LIST OF POSSIBLE SAMPLES IS ATTACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7227429 ↗
• InjuryOct 26, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT THE PATIENT HAS EXPERIENCED PAIN OVER HER MEDIAL FEMORAL CONDYLE.

  Patient problems: Osteolysis; Pain

  MAUDE report 6979038 ↗