LCS COMPLETE 1294-05-515Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295022107), received between Aug 3, 2017 and Apr 11, 2024 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 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.

• InjuryApr 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS REVISED DUE TO PAIN, INSTABILITY, AND A CATASTROPHIC POLY FAILURE DUE TO A BROKEN POST. DOI: UNKNOWN. DOR: (B)(6) 2024 . AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity; Pain

  MAUDE report 19086778 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD MEDIAL/LATERAL INSTABILITY. ALL COMPONENTS WERE WELL FIXED. SOFT TISSUE AND LIGAMENTS WERE INTACT. INCREASED POLY THICKNESS TO 22.5MM TO GAIN STABILITY. NO OTHER INFORMATION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 16022623 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO UNSTABLE KNEE. THERE WAS LOOSENING OF TIBIA AT THE CEMENT IMPLANT INTERPHASE. TIBIAL TRAY WAS SUBSIDED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2012. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT KNEE

  Patient problems: Joint Laxity

  MAUDE report 15743844 ↗
• InjuryJun 23, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO UNSTABLE POLY AND VERY LITTLE WEAR. DOI: UNKNOWN, AFFECTED SIDE: LEFT KNEE.

  Patient problems: Joint Laxity

  MAUDE report 14786998 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 14461360 ↗
• InjuryMay 25, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT'S KNEE WAS REVISED TO ADDRESS PAIN. NO LOOSENING AND NO DELAY IN SURGERY REPORTED. DOI: UNK. DOR: (B)(6) 2021. RIGHT KNEE

  Patient problems: Pain

  MAUDE report 11879283 ↗
• MalfunctionOct 23, 2020Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION OF LCS COMPLETE REVISION FEMUR RIGHT SIDE BECAUSE OF PAIN AND INSTABILITY. INTRAOPERATIVELY THE FEMORAL COMPONENT WAS FOUND TO BE FRACTURED. PATIENT IS SUFFERING FROM PARKINSON DISEASE AND SUFFERED A TRAUMA. NO SURGICAL DELAY. ON (B)(6) 2020, THE SURGEON DESCRIBED THE CONDITION/STATUS THAT LED TO REVISION ON (B)(6) 2015. IN ADDITION ON THIS DATE HE SUSPECTED THAT THE COMPONENTS IMPLANTED ON (B)(6) 2015 LOOSENED AS WELL.

  Patient problems: No Code Available; Pain

  MAUDE report 10726760 ↗
• InjuryAug 17, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATELLA WAS RESURFACED AND THIS WAS THE MEANING OF THE STATEMENT INDICATING PATELLA ADDED.

  Patient problems: No Code Available; Pain

  MAUDE report 10414432 ↗
• InjuryJan 21, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. ORIGINAL IMPLANT DATE UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9613498 ↗
• InjuryJan 3, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE BILATERAL KNEE POLY SWAP FOR INFECTION. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT SIDE KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9547018 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD KNEE REVISION FOR PAINFUL, STIFF KNEE. COMPONENTS WERE NOT LOOSE & NO INFECTION WAS PRESENT. FEMORAL COMPONENT, POLY INSERT, & PATELLA WERE REMOVED. SYNOVECTOMY, RELEASES & REMOVAL OF OSTEOPHYTES WAS PERFORMED. NEW COMPONENTS WERE IMPLANTED W/O INCIDENT. THERE IS NO OTHER INFORMATION TO BE OBTAINED.

  Patient problems: No Code Available; Pain

  MAUDE report 8431655 ↗
• InjuryAug 10, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS. DOI: (B)(6) 2006. DOR: (B)(6) 2018. LEFT KNEE.

  Patient problems: No Code Available; Not Applicable; Pain

  MAUDE report 7771921 ↗
• InjuryJan 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION TOTAL KNEE REPLACEMENT. DR (B)(6), (B)(6) ON (B)(6) 2017. PATIENT UNDERWENT PRIMARY TKR (B)(6) 2009 (DR (B)(6), (B)(6)). PATIENT PRESENTED AT 6 MONTH FOLLOW UP WITH A SOMEWHAT STIFF KNEE. PATIENT HAS THEN DISAPPEARED FROM FOLLOW UP AND HAS PRESENTED RECENTLY WITH A PAINFUL AND STIFF KNEE, WITH A RANGE OF MOTION OF 15-45 DEGREES. A DECISION WAS MADE TO REVISE THE KNEE. ON OPENING THE KNEE, THE COMPONENTS WERE WELL FIXED. RADIAL SCRATCHES WERE EVIDENT ON THE TIBIAL TRAY, ONCE THE INSERT HAD BEEN REMOVED. THE POSTERIOR CAPSULE WAS RELEASED ALONG WITH THE MOBILISATION OF THE MEDIAL AND LATERAL GUTTERS. ALL COMPONENTS WERE REMOVED AND A PFC TC3 RP IMPLANTED (WITH SLEEVES AND STEMS) THE KNEE WAS ABLE TO FULLY EXTEND AND PASSIVELY FLEX TO APPROXIMATELY 115 DEGREES. MALE PATIENT INITIALS (B)(6), AGED (B)(6), DOB (B)(6). DOI: (B)(6) 2009; DOR: (B)(6) 2017; UNKNOWN KNEE.

  Patient problems: Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 7160191 ↗
• InjuryNov 4, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  DER STATES THAT THE ORIGINAL IMPLANT DATE WAS UNKNOWN. THE PATIENT HAD A SUDDEN ONSET OF PAIN AND ACUTE INFLAMMATION IN HER LCS TKA SHE HAD IMPLANTED SOME TIME AGO. THE SURGEON DECIDED TO DO AN I&D AND SWAP OUT THE STD PLUS 15MM POLY AND STD + POLY ON A METAL BACK PATELLA. THE PRODUCTS THAT WERE EXPLANTED ARE LISTED ON DER EXCEPT THAT CATALOG NUMBER AND LOT NUMBER OF THE PATELLA. THE TIBIAL TRAY, FEMUR AND METAL BACK PATELLA WERE LEFT IMPLANTED/ THERE ARE NO LOT NUMBERS OF IMPLANTS THAT WERE LEFT IN THAT I CAN REPORT. THERE IS NO OTHER INFORMATION I AM ABLE TO PROVIDE, THE SURGEON AND STAFF COULD NOT TELL ME WHERE OR WHEN, OR WHO DID THE ORIGINAL SURGERY.

  Patient problems: Inflammation; Pain

  MAUDE report 7002212 ↗
• InjuryAug 3, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS PAIN. IT WAS ALSO NOTED THAT PATIENT WAS TESTED FOR INFECTION.

  Patient problems: Pain

  MAUDE report 6763171 ↗