LCS COMPLETE POROCOAT 1294-04-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295021766), received between Aug 30, 2017 and Nov 24, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 Laxity; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 23630372 ↗
• 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 22849879 ↗
• InjuryNov 9, 2023Patient Device Interaction Problem; Patient Device Interaction Problem

  LITIGATION COMPLAINT RECEIVED (B)(6) 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 18101191 ↗
• InjuryAug 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE TOTAL KNEE ARTHROPLASTY WITH THE MBT AND THE LCS FOR THE LEFT KNEE JOINT AT ANOTHER HOSPITAL. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, THE PATIENT WAS INFECTED WITH PSEUDOMONAS AERUGINOSA. THE IMPLANTS WILL NOT BE RETURNED BECAUSE THE PATIENT WAS INFECTED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15199371 ↗
• InjuryJul 5, 2022Loss of or Failure to Bond; Loss of or Failure to Bond

  IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT UNDERWENT AN UNKNOWN SURGERY. AFTER SURGERY, INFECTION OCCURRED. SINCE THE INFECTION HAS LOOSENED BOTH THE FEMUR AND TIBIA, THE SURGEON INTENDS TO PERFORM A REVISION IN 2 STAGES. ON (B)(6) 2022, THE 1ST REVISION SURGERY WAS PERFORMED SUCCESSFULLY. THE IMPLANTS USED IN THE INITIAL SURGERY WERE REMOVED, AND A MOLD WAS NEWLY USED FOR THE TREATMENT. ON (B)(6) 2022, THE 2ND REVISION SURGERY WILL BE PERFORMED WITH ATTUNE IMPLANTS. DOI: (B)(6) 2016. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 14914138 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. SURGEON CLAIMED THE PRIMARY IMPLANT FEMORAL JOINT LINE WAS RAISED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 14877452 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY IMPLANT DATE: (B)(6) 2019. PATELLA RESURFACING AND BEARING CHANGE INVOLVING THE LATERAL RELEASE OF PATELLA TENDON FOR FIXED FLEXION DEFORMITY AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 10097164 ↗
• InjuryAug 27, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY SURGERY MATER PRIVATE BRISBANE (B)(6) 2014: REASON FOR REVISION: GENERALISED PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; No Code Available; Pain

  MAUDE report 8934889 ↗
• InjuryMar 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD AN LCS KNEE REVISED FOR INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8424632 ↗
• InjuryJun 12, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  REVISION FEMORAL COMPONENT DUE TO FEMORAL CONDOLE COLLAPSE; (B)(6) 2018. PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2018 WHERE AN LCS WAS IMPLANTED - (DR (B)(6)). PATIENT HAS PRESENTED WITH A PAINFUL KNEE WHICH APPEARS TO BE IN GROSS VALGUS. X RAYS INDICATE COLLAPSE OF THE LATERAL FEMORAL CONDYLE AND THE FEMORAL COMPONENT NOW SITTING IN GROSS VALGUS. TIBIAL COMPONENT APPEARS WELL FIXED. THE FEMORAL COMPONENT WAS REMOVED AND A STEMMED MODULAR LCS COMPONENT WITH A LATERAL AUGMENT WAS STABLE AND FUNCTIONING WELL ON THE TABLE. FEMALE PATIENT (B)(6).

  Patient problems: Bone Fracture(s); Not Applicable; Pain

  MAUDE report 7591273 ↗
• InjuryDec 4, 2017Loss of or Failure to Bond; Loss of or Failure to Bond

  DER STATES THAT THE PATIENT HAD DEPUY LCS KNEE SYSTEM PRIOR. PATIENT WAS COMING CLOSE TO 20 YEARS OF IMPLANTATION. SURGEON DECIDED TO REMOVE THE IMPLANTS AND PUT IN NEW REVISION IMPLANTS. UPDATE OCT 26, 2017 : TIBIAL TRAY LOOSENING. LOOSENING OCCURRED FROM CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. THIS COMPLAINT WAS UPDATED ON OCT 26, 2017. UPDATE NOV 30, 2017: ADDITIONAL INFORMATION RECEIVED. THERE WAS TIBIAL AND FEMORAL LOOSENING. THIS COMPLAINT WAS UPDATED ON DEC 1, 2017.

  Patient problems: No Information

  MAUDE report 7079151 ↗
• InjuryNov 14, 2017Ambient Noise Problem; Ambient Noise Problem

  THE PATIENT WAS REVISED TO ADDRESS PATELLA "CLUNKING".

  Patient problems: No Code Available

  MAUDE report 7029663 ↗
• InjuryAug 30, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6830875 ↗