LCS COMPLETE 1294-05-310Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295021940), received between Oct 26, 2017 and Sep 10, 2025 — classified as 13 injuries, 1 malfunction.

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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA FOR OA ON THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY AND THE TIBIAL TRAY WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2025, THE PATIENT WAS IN PAIN AND WAS EXAMINED, WHICH REVEALED A SUSPECTED INFECTION. IMPLANT REMOVAL IS PLANNED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23015710 ↗
• InjurySep 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT UNDERWENT AN INITIAL SURGERY VIA TKA FOR OA ON THE KNEE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2019, THE PATIENT UNDERWENT A REVISION SURGERY AND THE TIBIAL TRAY WAS REPLACED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. IN (B)(6) 2025, THE PATIENT WAS IN PAIN AND WAS EXAMINED, WHICH REVEALED A SUSPECTED INFECTION. IMPLANT REMOVAL IS PLANNED.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23015571 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MOBILIZATION OF THE ENTIRE LEFT KNEE IMPLANT. REVISION SURGERY NEEDED. DOI: (B)(6) 2021, DOR: (B)(6) 2023.

  Patient problems: Joint Laxity

  MAUDE report 18065988 ↗
• InjuryJun 10, 2022Unintended Movement; Unintended Movement

  PATIENT WAS REVISED DUE TO THE INSERT SPUN OUT. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6)2022, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 14654965 ↗
• MalfunctionMay 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON AN UNKNOWN DATE, THE PATIENT UNDERWENT THE SURGERY WITH THE LCS IMPLANTS IN QUESTION. AFTER THE SURGERY, A REVISION SURGERY IS PLANNED ON (B)(6) 2022. DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14540289 ↗
• InjuryJan 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT ALLERGY LCS TI NI, ALLERGY CEMENT. DOI: (B)(6) 2020. DOR: (B)(6) 2022, UNKNOWN SIDE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13392009 ↗
• InjurySep 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT A SURGERY TREATING THE KNEE JOINT. ON (B)(6) 2021, BECAUSE OF INFECTION, ALL IMPLANTS WERE REMOVED, AND A CEMENT MOLD WAS INSERTED. THE SURGERY WAS COMPLETED WITHOUT ANY SURGICAL DELAY. THE PATIENT IS SCHEDULED TO UNDERGO REVISION SURGERY IN 6 WEEKS. DOI: (B)(6) 2019, DOR: (B)(6) 2021, UNKNOWN SIDE.

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

  MAUDE report 12497033 ↗
• InjuryAug 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION. ALL IMPLANTS WERE EXPLANTED. DOI: (B)(6) 2015; DOR: (B)(6) 2021; RIGHT KNEE.

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

  MAUDE report 12327314 ↗
• InjuryJun 9, 2021Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Osteolysis

  MAUDE report 11965382 ↗
• InjuryMay 10, 2021Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT TKA FOR RIGHT OA WITH THE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. AFTER THE SURGERY, ON (B)(6) 2021, WHEN THE PATIENT TRIED TO STAND UP FROM THE CHAIR, FELT PAIN IN THE KNEE AND COULD NOT BEND. X-RAY REVEALED THAT THE INSERT HAD SPUN OUT. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY ON (B)(6) 2021. NO FURTHER INFORMATION AVAILABLE.

  Patient problems: Pain

  MAUDE report 11798304 ↗
• InjuryApr 16, 2021Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE POLY WAS WORN. SURGEON EXCHANGE THE POLY AND RESURFACED THE PATELLA. NO SURGICAL DELAY. THERE WAS NOT ANY INSTRUMENT BROKEN. DOI: (B)(6) 2003, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 11677785 ↗
• InjuryMar 9, 2021Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO SEVERE MEDIAL POSTERIOR WEAR. ORIGINAL INSERT IMPLANTED 20+ YEARS AGO. DOI: 20+ YEARS AGO DOR: (B)(6) 2021 RIGHT KNEE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11446126 ↗
• InjuryJan 4, 2021Naturally Worn; Naturally Worn

  DELAMINATION OF LCS INLAY AND PATELLA AFTER 11 YEARS.

  Patient problems: Insufficient Information

  MAUDE report 11108582 ↗
• InjuryOct 26, 2017Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY AND POLYETHYLENE WORN.

  Patient problems: No Information

  MAUDE report 6979243 ↗