LCS COMPLETE 1294-05-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295022022), received between Oct 26, 2017 and Nov 14, 2025 — classified as 32 injuries.

The most frequently reported specific device problem is “Naturally Worn” (4 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 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• InjuryNov 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CHANGED LCS POLY TO A THICKER SIZE. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 23559699 ↗
• 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 22849881 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A BILATERAL POLY WASHOUT DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 22505753 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A REVISION SURGERY DUE TO MID FLEXION INSTABILITY. THE REVISION JUST INVOLVED SWAPPING THE POLY TO 5MM THICKER (UP TO 17.5MM POLY). WITHIN 3 WEEKS AFTER THIS SHE WAS BACK TO NORMAL.

  Patient problems: Joint Laxity

  MAUDE report 21943168 ↗
• InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING, NO SURGICAL DELAY.

  Patient problems: Pain

  MAUDE report 20493311 ↗
• InjuryMay 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 19280576 ↗
• InjuryApr 18, 2024Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY? NO DELAY. B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? LEFT.

  Patient problems: Pain

  MAUDE report 19134257 ↗
• InjuryMar 13, 2024Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  POLY EXCHANGE WAS REPORTED FOR A LCS TKR. IT WAS REPORTED THAT THE POLY HAD WEAR AND THE BEARING STARTED TO SPIN OUT FOR THE PATIENT GIVING HER THE UNSTABLE FEELING. NO INFECTION DOI: (B)(6) 2009 AFFECTED SIDE: LEFT

  Patient problems: Joint Laxity

  MAUDE report 18893353 ↗
• InjurySep 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INSTABILITY. DOI: (B)(6) 2012. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 17778237 ↗
• InjurySep 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO A LOOSE KNEE. THE INSERT WAS UPSIZED. NO FURTHER INFORMATION IS AVAILABLE. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2018. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15500585 ↗
• 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)(6) 2022, RIGHT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 15232832 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2010. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14576961 ↗
• InjuryJun 2, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 14576543 ↗
• InjuryDec 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPLAINTS WERE EXTRACTED FROM THE ATTACHED FILE "SERVICE EVALUATION OF THE LCS TINI PRODUCT". LOOSENING (4X): 2X 1-2 YEARS AFTER SURGERY, 1X 2-3 YEARS AFTER SURGERY, 1X 3-5 YEARS AFTER SURGERY. INFECTION (3X): 1X LESS THAN 1 YEAR, 1X 3-5 YEARS AFTER SURGERY, 1X 5-10 YEARS AFTER SURGERY, OTHER (1X), 1X 2-3 YEARS AFTER SURGERY (SOFT TISSUE REVISION ONLY - PERMANENT PROBLEMS, LUMP, EFFUSION ETC.) THIS COMPLAINT CAPTURES 1 WITH LOOSENING 3-5 YEARS AFTER SURGERY. ON (B)(6) 2010, THE PATIENT HAD A TOTAL KNEE REPLACEMENT RIGHT KNEE. IT WAS NOTED THAT THE PATIENT IS ALLERGIC TO NICKEL. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. NO INTRAOPERATIVE COMPLICATIONS WERE NOTED. ON (B)(6) 2014, XRAY WAS NOTED TO SHOW A RADIOLUCENT LINE FORMATION ON THE FEMORAL PART. A MOBILIZATION UNDER ANESTHESIA WAS PERFORMED TO RELEASE SCAR TISSUE. ON (B)(6) 2014 PATIENT WAS REVISED. REVISION DETAILS INCLUDED INSUFFICIENCY OF THE MEDIAL COLLATERAL LIGAMENTS, WHICH LEAD TO THIS IMPLANT EXCHANGE. (INSTABILITY) DURING THE PROCEDURE THE SURGEON OBSERVED OSSUS OVERGROWTH OF THE IMPLANT EDGES WHICH WERE REMOVED. FEMORAL, TIBIAL TRAY, AND INSERT WERE REVISED.

  Patient problems: Joint Laxity; Scar Tissue

  MAUDE report 13017879 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE LEG BECAME LOOSE OVER TIME. BIGGER BEARING REQUIRED. DOI: UNKNOWN, DOR: (B)(6) 2021, (LEFT KNEE).

  Patient problems: Joint Laxity

  MAUDE report 12471070 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS UNSTABLE KNEE AND NEEDED A BIGGER POLY. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12470825 ↗
• InjuryApr 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE REPLACEMENT FOR INSTABILITY IN FLEXION. ALSO PATELLA TILT. BEARING CHANGED AND PATELLA REVISED. PREVIOUS PATELLA COMPONENT REMOVED AND PATELLA BONE RESECTED ANOTHER 5MM. BEARING CHANGED TO A THICKER BEARING TO ADDRESS INSTABILITY AND PATELLA REVISED AND RESURFACED WITH A FURTHER RESECTION OF PATELLA BONE AND A PATELLA RE-IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 11640675 ↗
• InjuryJan 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. A SWAP FOR A THICKER POLY WAS DONE. THE ORIGINAL IMPLANTATION DATE IS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11185721 ↗
• InjuryNov 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 10896456 ↗
• InjuryAug 4, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRIMARY KNEE WAS PLACED IN VARUS AND THE PATIENT WAS UNHAPPY WITH THE RESULT AND COMPLAINED OF INSTABILITY. REVISED TO ATTUNE REVISION.

  Patient problems: Discomfort; No Code Available

  MAUDE report 10362915 ↗
• 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 10097173 ↗
• InjuryMay 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SOME OF THE PROBLEMS I'VE HAD PHYSICALLY SINCE THIS IMPLANT, AND SPECIFICALLY SINCE 2016 ARE: HEART FLUTTERING, HEARTBURN, KIDNEY/LIVER READING ELEVATED, SKIN RASHES AND ITCHING, HEADACHES, CONTINUAL COUGHING, NODUAL IN THROAT, AT TIMES, PAIN IN LEFT KNEE, STRUGGLE TO WALK, ACHY JOINTS, TINNITUS, VISION ISSUES. DOI: (B)(6) 2006. DOR: REVISION SCHEDULE (A FEW MONTHS LATER). RIGHT KNEE.

  Patient problems: Headache; Heartburn/Indigestion; Itching Sensation; No Code Available; Pain; Rash; Tinnitus

  MAUDE report 10072430 ↗
• InjuryDec 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS RIGHT KNEE INSTABILITY. DOI: (B)(6) 2007; DOR: (B)(6) 2019; AFFECTED SIDE (RIGHT KNEE).

  Patient problems: No Code Available

  MAUDE report 9483097 ↗
• InjuryOct 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9167528 ↗
• InjuryOct 7, 2019Naturally Worn; Naturally Worn

  PATIENT WAS REVISED TO ADDRESS POLY WEAR. 12.5MM INSERT WAS REMOVED AND REPLACED WITH 17.5MM INSERT. IMPLANT REFERENCE AND LOT NUMBERS WERE UNREADABLE. ORIGINAL IMPLANT DATE UNKNOWN. DOI: 12 YEARS AGO; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9162729 ↗