LCS COMPLETE POROCOAT 1294-04-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295021773), received between Oct 6, 2017 and Dec 4, 2025 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 23720881 ↗
• InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT KNEE BECAME UNSTABLE. SURGEON ATTEMPTED TO SWAP THE POLY FOR A LARGER SIZE, BUT HAD TO REMOVE/REPLACE THE FEMUR AND POLY. DOI: (B)(6) 2017. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 23286347 ↗
• InjuryJul 8, 2024Migration; Migration

  SURGEON REVISED ONE OF HIS LCS TKR DUE TO SUBSIDENCE OF THE FEMORAL COMPONENT. REVISED TO ATTUNE REVISION. IMPLANTS APPEARED TO HAVE BONE ON-GROWTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696891 ↗
• InjuryApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO SURGICAL DELAY RELATED TO THE EVENT.

  Patient problems: Fall

  MAUDE report 19104722 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. A. CAN YOU PLEASE PROVIDE THE AFFECTED SIDE? -IT IS THE LEFT KNEE. B. WAS INSTABILITY RELATED TO POLYETHYLENE WEAR OR JUST LACK OF PCL? -LACK OF PCL. C. CAN YOU CONFIRM IF DEPUY CEMENT WAS USED DURING THE PRIMARY SURGERY? IF YES, PLEASE PROVIDE THE PART AND LOT NUMBERS OF THE CEMENT. QUANTITY OF THE DEPUY CEMENT USED. -CANNOT DETERMINE.

  Patient problems: Joint Laxity; Loss of Range of Motion; Pain; Unspecified Tissue Injury

  MAUDE report 16487628 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO POSSIBLE INFECTION. THE SURGEON DECIDED TO CHANGE THE INSERT AND RESURFACE PATELLA. THE PATELLA WAS NOT ORIGINALLY DONE IN THE 1ST SURGERY IN 2017.

  Patient problems: Foreign Body Reaction; Unspecified Infection

  MAUDE report 15987565 ↗
• InjuryDec 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OS LCS PRIMARY TOTAL KNEE; REVISED FOR PAIN. NIL KNOWN DATE FOR ORIGINAL PRIMARY SURGERY; NIL KNOWN ORIGINAL SURGEON DETAILS; REVISED TO LCS REVISION. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 12984654 ↗
• InjuryApr 13, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT HAS NOT BEEN HAPPY WITH KNEE SINCE IT WAS IMPLANTED AND COMPLAINING OF PAIN. SURGEON HAD SCANS OF THE KNEE DONE, AND SOME HOT SPOTS SHOWED UP AROUND THE KNEE. SURGEON THOUGHT MAYBE THE IMPLANT WAS LOOSE. WHEN REMOVING THE IMPLANT, THE SURGEON STATED THE IMPLANT WAS NOT LOOSE BUT STILL REMOVED DUE TO PATIENTS REQUEST.

  Patient problems: No Code Available; Pain

  MAUDE report 9954217 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH SYMPTOMS CONSISTENT WITH INFECTION OF THE TOTAL KNEE. THE PATIENT HAD A FEVER AND THE OPERATIVE KNEE WAS RED AND SWOLLEN. SURGEON DREW LABS AND ASPIRATED THE KNEE. THE LABS WERE ELEVATED CONSISTENT WITH INFECTION, ALSO THE ASPIRATE GREW OUT BACTERIA. SURGEON THEN TOOK THE PATIENT TO SURGERY TO REMOVE THE IMPLANTS TO WASHOUT AND PLACE ANTIBIOTIC SPACER. IMPLANTS WERE ALL WELL FIXED. IMPLANTS WERE REMOVED WITH VERY LITTLE BONE LOSS. ANTIBIOTIC SPACERS WERE PLACED. DEPUY CEMENT WAS USED. UPDATE: DEPUY 2 CEMENT REF# (B)(4), LOT# 8770435 WAS USED DURING THE PRIMARY KNEE PROCEDURE ON 1/29/19 TO CEMENT THE TIBIA AND PATELLA. THE IMPLANTS WERE FOUND TO BE WELL FIXED AT THE TIME OF THE EXPLANT PROCEDURE. DOI: (B)(6) 2019, DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: Fever; Injury; No Code Available; Swelling; Unspecified Infection

  MAUDE report 8451089 ↗
• InjuryApr 9, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REASON FOR REVISION: (B)(6) 2018: METALLOSIS.

  Patient problems: Not Applicable; Tissue Damage

  MAUDE report 7407334 ↗
• 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 6926003 ↗