LCS COMPLETE 1294-05-417Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295022046), received between Aug 1, 2017 and Sep 18, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT POLY EXCHANGE PROCEDURE. PATIENT EXPERIENCED POLY SPINOUT IN BOTH KNEES. THE SURGEON'S OPINION WAS THAT THERE WAS LOOSENING OF THE PATIENT'S COLLATERAL LIGAMENTS OVER TIME, GIVING THE POLY SPACE TO SPIN OUT. SURGEON WAS UNSURE WHETHER A FALL OR MOVEMENT WAS INVOLVED AS WELL, BUT CONSIDERED PATIENT FACTORS TO BE INVOLVED. THERE WAS NO DELAY IN SURGERY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 23082444 ↗
• InjurySep 18, 2025Naturally Worn; Unintended Movement; Naturally Worn; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED LCS POLY DISLOCATION AND CHANGE. THERE WAS NO INFECTION. SURGEON REPLACED 10MM POLY WITH 17.5MM POLY. IT WAS FURTHER REPORTED THAT THE POLY HAD SPUN OUT FOR BOTH KNEES, AND BOTH POLYS WERE REPLACED. THE SURGEON'S OPINION WAS THAT THERE WAS LOOSENING OF THE PATIENT'S COLLATERAL LIGAMENTS OVER TIME, GIVING THE POLY SPACE TO SPIN OUT. SURGEON WAS UNSURE WHETHER A FALL OR MOVEMENT WAS INVOLVED AS WELL, BUT CONSIDERED PATIENT FACTORS TO BE INVOLVED.

  Patient problems: Joint Laxity; Unspecified Tissue Injury

  MAUDE report 23082390 ↗
• InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD THEIR LCS PRIMARY IMPLANTED FOR MEDIAL COMPARTMENT ARTHRITIS. INITIAL SURGERY WAS UNEVENTFUL BUT PATIENT UNDERWENT MANIPULATION UNDER ANAESTHESIA 12 WEEKS POST OP WHEN KNEE MOTION THEN INCREASED 73-120 DEGREES. THIS WAS THEN REVISED IN 2021 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 WAS REVISED AGAIN ON (B)(6) 2025 AS PATIENT WAS EXPERIENCING MORE INSTABILITY WHICH HAS CAUSED PATIENT TO FALL MANY TIMES. PATIENT REACHED A POINT WHERE PATIENT DIDN'T TEND TO FLEX THE RIGHT KNEE AND WALKS WITH A STIFFER KNEE GAIT PRESUMABLY DUE TO THE DEGREE OF INSTABILITY. THERE WERE NO INDICATIONS OF LOOSENING. THIS REPORT CAPTURES SECOND REVISION PROCEDURE PERFORMED ON (B)(6) 2025 DUE TO INSTABILITY WHILE RELATED COMPLAINT (B)(4) CAPTURES THE FIRST REVISION FOR TIBIAL INSERT ONLY WHICH WAS PERFORMED IN 2021.

  Patient problems: Ambulation or Postural Difficulties; Fall; Joint Laxity

  MAUDE report 21936842 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THE CEMENT MANUFACTURER WAS NOT INDICATED. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 16014402 ↗
• InjuryNov 24, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2009, THE PATIENT UNDERWENT THE TKA SURGERY FOR RIGHT KNEE JOINT WITH THE INSERT IN QUESTION. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. ON (B)(6) 2021, IT WAS CONFIRMED THAT THE INSERT HAD SPUN OUT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Joint Laxity

  MAUDE report 12868470 ↗
• InjuryAug 24, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLYETHYLENE INSERT WAS EXCHANGED DUE TO INSTABILITY AND POLYETHYLENE WEAR. DOI: UNKNOWN, DOR: (B)(6) 2021, UNKNOWN KNEE.

  Patient problems: Joint Laxity

  MAUDE report 12361268 ↗
• InjuryJan 15, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO UNSTABLE KNEE. WENT UP IN POLY SIZE. NO SURGICAL DELAY. DOI: (B)(6) 2015. DOR: (B)(6) 2021. LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 11177886 ↗
• InjurySep 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL PARTS EXPLANTED AND REPLACED WITH A STATIC SPACER. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10595756 ↗
• InjurySep 16, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TOTAL KNEE REPLACEMENT. PRIMARY TKR (B)(6) 2016 AFTER PREVIOUS FULKINSON OSTEOTOMY. THEN ITB RELEASE (DR (B)(6) DATE UNKNOWN. INSTABILITY IS REASON FOR CURRENT REVISION. BEARING CHANGE TO 25MM BEARING AND NATIVE PATELLA RESURFACED.

  Patient problems: No Code Available

  MAUDE report 10541759 ↗
• InjuryMay 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS KNEE FOR INSTABILITY 2ND REVISION, PRIMARY IMPLANT DATE: (B)(6) 2013. FEMORAL AND TIBIAL AND PATELLA COMPONENTS RETAINED, WASHOUT AND NEW INSERT TRIALED. 22.5MM STD INSERT PUT IN AND THE KNEE WAS STABLE. THE SURGEON HAD BEEN ADVISED ON THE FIRST REVISION TO USE A THICKER INSERT BUT HAD FELT IT WAS STABLE. NO AE REPORTED.

  Patient problems: No Code Available

  MAUDE report 10075261 ↗
• 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 8424630 ↗
• InjuryJan 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INSTABILITY AND PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8254313 ↗
• InjuryDec 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED FOR PAIN.

  Patient problems: Pain

  MAUDE report 7128318 ↗
• InjuryNov 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY.

  Patient problems: Pain

  MAUDE report 7023428 ↗
• InjuryAug 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL KNEE DUE TO INFECTION.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 6756383 ↗