LCS COMPLETE POROCOAT 1294-03-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295021711), received between Oct 20, 2017 and Sep 23, 2024 — classified as 11 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (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.

• InjurySep 23, 2024Adverse Event Without Identified Device or Use Problem; 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 20279542 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS TOTAL KNEE. REVISION DUE TO INSTABILITY AND PAIN. METALLOSIS WAS ALSO NOTED IN THE JOINT.

  Patient problems: Foreign Body Reaction; Joint Laxity; Pain

  MAUDE report 19088739 ↗
• 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 18453376 ↗
• 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 15013849 ↗
• InjuryJun 15, 2022Fracture; Fracture

  REVISION SURGERY OF LCS FROM 2012. THE POSTERIOR CONDYLE OF THE FEMUR HAS FRACTURED OFF IN SITU. VISUALISED ON XRAY AND CT AND FOUND IN SURGERY. IN ADDITION IT WAS A LATE DISCOVERY AND THE ONLY KIT WE COULD GET TO THE HOSPITAL WITH IT A 12 HOUR TIME PERIOD WAS A HINGE. DOI: 2012; DOR: (B)(6) 2022; UNKNOWN SIDE.

  Patient problems: Insufficient Information

  MAUDE report 14696816 ↗
• 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 10734827 ↗
• InjuryNov 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED TO PUBLIC HOSPITAL WITH PUS/BOIL WOUND ON RIGHT KNEE - WHERE SCAR FROM TKR WAS. BLOODS DONE AND ELEVATED IN INFECTION MARKERS - WASHOUT DECIDED UPON + POLY CHANGE. DURING SURGERY IT WAS DISCOVERED THAT THE PUS AREA TRACKED DOWN INTO THE PROXIMAL TIBIA SO THE DECISION WAS MADE TO DO A FIRST STAGE REVISION AND REMOVE ALL IMPLANTS. INFECTION TO BE TREATED AND THEN A 2ND STAGE REVISION TKR TO BE PERFORMED IN 6-8 WEEKS.

  Patient problems: Adhesion(s); No Code Available; Unspecified Infection; Wound Dehiscence

  MAUDE report 9322164 ↗
• 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 8639942 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  INFECTED KNEE. REMOVAL OF ALL IMPLANTS. NO EXTRA SURGICAL TIME NEEDED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8550909 ↗
• InjuryDec 10, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8146284 ↗
• MalfunctionDec 20, 2017Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  THE TWO TRANSPARENT CASINGS WHICH HOUSE THE IMPLANT WERE TIGHTLY STUCK TOGETHER RESULTING IN THE SCRUB NURSE STRUGGLING TO REMOVE THE INNER STERILE CASE. THE TAB THE SCRUB NURSE USES TO REMOVE THE INNER CASING BROKE OFF. THE SCRUB NURSE THEN HAD TO USE A FORCEPS TO REMOVE. DOI: (B)(6) 2017

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7133033 ↗
• InjuryOct 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  COMPLAINT DESCRIPTION: THE PATIENT WAS REVISED TO ADDRESS PAIN. UPDATE 9-22-2017 AND 9-27-2012. MEDICAL RECORDS REVIEWED. PRE- REVISION NOTES INDICATE UPON CLINICAL EXAMINATION, THE PATIENTS KNEE IS SWOLLEN. THERE IS A LARGE EFFUSION PRESENT. X-RAYS TAKEN REVEALED A LARGE AREA OF LYSIS IN THE ANTERIOR PART OF THE PEG IN THE TIBIA AND NO EVIDENCE OF ANY FRACTURE, HOWEVER IT DID LOOK EXPANSIVE. BRIEF REVISION OPERATIVE NOTE JUN 22, 2015 REVEALS THE PATIENT RECEIVED A FIRST STAGE EXCISION ARTHROPLASTY RIGHT KNEE. FINDINGS INCLUDE GROSS TIBIAL LYSIS, TIBIAL MEDIAL DEFECT BENEATH MCL, PATELLAR TENDON WITH TUBERCLE STILL ATTACHED. NO ANTEROMEDIAL BONE. CORTICAL SHEEL OF LOOSE FRACTURED ANTEROLATERAL TIBIA. THE SURGEON DETERMINED THE JOINT WAS NOT RECONSTRUCTABLE WITH TC3 & AUGMENTS DUE TO CONCERNS ABOUT UNDERLYING INFECTION. PROXIMAL TIBIAL 1ST STAGE CARRIED OUT WITH SPACER & DEBRIDEMENT. MEDICAL RECORDS INDICATE THE PATIENT WAS RE-IMPLANTED IN SEP 2015, IT IS UNKNOWN WHAT PRODUCTS WERE IMPLANTED AT THIS TIME. IT IS THEN INDICATED THAT A RIGHT TRANSTIBIAL AMPUTATION WAS PERFORMED ON (B)(6) 2015 DUE TO PERSISTENTLY INFECTED RIGHT PROXIMAL TIBIAL REPLACEMENT WITH GRAFT /FLAP BREAKDOWN. INS

  Patient problems: Bone Fracture(s); Joint Swelling; Osteolysis; Pain; Tissue Damage

  MAUDE report 6965255 ↗