LCS COMPLETE 1294-05-710Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 10603295022220), received between Oct 18, 2017 and Jul 27, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Naturally Worn” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Naturally Worn

  It was reported that the patient had primary left TKA surgery done on (b)(6) 2007, where a DePuy MBT Duofix Tray Size 4, LCS Complete Duofix Femoral HA Coated Left Lrg+ & LCS Complete RP Insert Sz Lg+ 10mm were implanted. These were then revised on (b)(6) 2012 due to pain, and polyethylene 3rd body wear. The femur was left insitu, the tibia was revised to a Tibial Tray Rotating Platform M.B.T Revision Size 4 Cemented, with a Universal Revision Stem 75 x14mm and an LCS Complete Tibial Insert Rotating Platform LCS RP 10mm Lg+ GVF.This complaint is related to (b)(4) which captures revision performed on (b)(6) 2026 due to to loosening of the femoral component due to cystic properties on x-ray and bone loss and poly wear of the bearing.

  Patient problems: Pain

  MAUDE report 50019879 ↗
• InjuryFeb 13, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THERE WAS A REVISION OF A LCS FEMUR AND INSERT, DUE TO POLY WEAR, PAIN, AND OSTEOLYSIS OF THE FEMORAL COMPONENT.

  Patient problems: Osteolysis; Pain

  MAUDE report 21376738 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WHAT WAS THE REASON FOR REMOVAL/ REVISION SURGERY? INVESTIGATIONS FOUND BONE RESORPTION IN FEMORAL CONDYLE. REPLACE POLY AND FILL BONE VOID WITH BONE GRAFT. B. WAS THERE ANY ADVERSE CONSEQUENCE TO THE PATIENT RELEVANT TO THIS EVENT? IF YES, PLEASE KINDLY PROVIDE DETAILS. YES - REVISION TKR, POLY EXCHANGE, BONE GRAFT.

  Patient problems: Insufficient Information; Unspecified Tissue Injury

  MAUDE report 19126860 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNK, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 17584676 ↗
• InjuryNov 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN. DOI: (B)(6) 1999; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 15717060 ↗
• InjuryJul 15, 2021Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO POLY WAS WORN ON MEDIAL SIDE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2021. RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12175983 ↗
• InjuryJun 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT PRIMARY LEFT TKR ON (B)(6) 2016 WHERE AN UNCEMENTED LCS FEMORAL COMPONENT AND AN UNCEMENTED LCS TIBIAL COMPONENT WERE UTILIZED PATIENT HAS REPORTED THAT THE KNEE HAS NEVER FELT RIGHT AND HAS HAD ONGOING LOW LEVELS OF DISCOMFORT. PATIENT HAS PRESENTED TO THE GOLD COAST UNIVERSITY HOSPITAL FOLLOWING A BUMP TO THE KNEE WITH SUBSEQUENT PAIN AND SWELLING. THE KNEE APPEARED TO BE INFECTED. A WASHOUT WAS PERFORMED (DATE AND SURGEON UNKNOWN) AND SAMPLES TAKEN. STAPH WAS GROWN/ CULTIVATED. DOI: (B)(6) 2016 DOE: UNKNOWN LEFT KNEE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Discomfort; Pain; Swelling/ Edema

  MAUDE report 12067733 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO EXTENSION TO THE SURGICAL TIME.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12051351 ↗
• InjuryJun 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A. PLEASE VERIFY IF THERE WAS A CONFIRMED INFECTION? 1) THERE WAS NO MICROBIAL CONFIRMATION IN EITHER THE ONE WEEK OR TWO WEEK CULTURES, HOWEVER DR (B)(6) STATED TO ME THAT HIS CONCLUSION WAS INFECTION DUE TO OSTEOLYSIS OF THE SURROUNDING TISSUE. B. STATED IN THE EVENT, "REASON FOR REVISION: TIBIAL LOOSENING." PLEASE CONFIRM WHAT INTERFACE WAS LOOSE. 2) THE BONE-CEMENT INTERFACE WAS LOOSE. C. WAS LOOSENING DUE TO INFECTION? 3) UNKNOWN, BUT THE LOOSENING WAS PRESUMED TO BE DUE TO INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Osteolysis

  MAUDE report 11994822 ↗
• InjuryJun 8, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10130011 ↗
• InjuryMar 24, 2020Fracture; Naturally Worn; Fracture; Naturally Worn

  REVISION OF LCS IMPLANTED IN 2011 BY (B)(6). PATIENT REPORTED PAIN AND DIFFICULTY MOBILISING, X-RAY REVEALED TIBIAL PERI-PROSTHETIC FRACTURE & OSTEOLYSIS ON THE LATERAL FEMORAL CONDYLE. ON REMOVAL OF THE IMPLANTS, MARKED DELAMINATION AND A LARGE CRACK ON THE MEDIAL SIDE OF THE POLYETHYLENE.

  Patient problems: Inflammation; Limited Mobility Of The Implanted Joint; No Code Available; Osteolysis; Pain

  MAUDE report 9871522 ↗
• InjuryMar 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN. DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9779713 ↗
• InjuryJun 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TOTAL KNEE REPLACEMENT; DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. PRIMARY IMPLANTED BY DR (B)(6) AT (B)(6) HOSPITAL, PRIMARY IMPLANT DATE UNKNOWN AND IMPLANT STICKERS UNAVAILABLE. REVISION FOR INSTABILITY AND PAIN BEARING CHANGED TO 12.5MM AND PATELLA RESURFACED. MALE PATIENT INITIALS: (B)(6), DOB: (B)(6). IMPACTED PRODUCT: UNKNOWN JRN: LGE+ 10MM LCS BEARING LOT NUMBER UNKNOWN = IMPLANT DISCARDED. RELATED PRODUCT: UNKNOWN JRN: LGE+ RT LCS POROUS FEMORAL COMPONENT/ LOT NUMBER UNKNOWN = STILL IMPLANTED. UNKNOWN JRN: SIZE 5 MBT CONE CEMENTED TIBIA/ LOT NUMBER UNKNOWN = STILL IMPLANTED.

  Patient problems: Pain

  MAUDE report 7628988 ↗
• InjuryMay 30, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: Not Applicable; Pain

  MAUDE report 7555587 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTED KNEE. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7391681 ↗
• InjuryMar 28, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PRIMARY: (B)(6) 2014. THIS IS PATIENT'S 1ST REVISION FOR STIFFNESS AND PAIN.

  Patient problems: Not Applicable; Pain

  MAUDE report 7378058 ↗
• InjuryOct 18, 2017Naturally Worn; Naturally Worn

  REVISION DUE TO INFECTION. (B)(6) 2013, MR (B)(6)'S KNEE STARTED TO DISCHARGE. HIS BLOOD TESTS ((B)(6) 2013) WERE ESR 65; CRP 29.5.(9.5.2013) ESR 63; CRP 25. THIS MAN HAS A DEFINITE INFECTION OF HIS KNEE. HIS SINUS HAS BEEN SWABBED TODAY. HE NOW REQUIRES AN URGENT TWO STAGE REVISION OF HIS INFECTED TOTAL KNEE REPLACEMENT. MR (B)(6)'S FIRST STAGE SHOULD BE DONE AS SOON AS POSSIBLE. IF HIS KNEE DRIES UP AND HIS CULTURES ARE CLEAR, HE MAY BE SUITABLE FOR A TWO STAGE REVISION AT ONE SITTING. STAGE 1 - REMOVAL OF DUOFIX KNEE REPLACEMENT. LETTER OF CLAIM RECEIVED 13 DEC 2016. ADDITIONAL INFORMATION CONFIRMED PAIN, SWELLING AND POOR RANGE OF MOVEMENT- (B)(6) 2016. UPDATE JUL 18, 2017: EMAIL NOTIFICATION FROM (B)(6) RECEIVED. EMAIL NOTIFICATION CONFIRMED THAT THIS COMPLAINT IS NOW BEING ACTIVELY LITIGATED. THIS COMPLAINT WAS UPDATED ON: AUG 15, 2017. SWELLING AND POOR RANGE OF MOVEMENT - (B)(6) 2016. UPDATE SEP 22, 2017. MEDICAL RECORDS REVIEWED. PRIMARY OPERATIVE NOTE (B)(6) 2007 INDICATES THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO OSTEOARTHRITIS. COMPLETED WITHOUT INDICATION OF COMPLICATION BY THE SURGEON. PROCEDURE NOTE (B)(6) 2012 INDICATE THE PATIENT RECEIVED A LEFT TOT

  Patient problems: Foreign Body Reaction; Joint Swelling; Loss of Range of Motion; Osteolysis; Pain; Unspecified Infection

  MAUDE report 6959367 ↗