LCS COMPLETE 1294-02-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10603295021636), received between Jan 29, 2018 and Sep 10, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 10 most recent of 10 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 23015733 ↗
• InjuryMay 8, 2024Loss of or Failure to Bond; Use of Device Problem; Loss of or Failure to Bond; Use of Device Problem

  ADDITIONAL INFORMATION WAS RECEIVED. INDICATING, THAT THERE WAS LOOSENING BETWEEN THE IMPLANT AND CEMENT.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 19272080 ↗
• InjuryJul 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL KNEE. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT KNEE.

  Patient problems: Pain

  MAUDE report 17299059 ↗
• 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 15744053 ↗
• InjuryApr 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LEFT LCS TOTAL KNEE REPLACEMENT FOR PERIPROSTHETIC FRACTURE OF FEMUR. FEMORAL FRACTURE PROXIMAL TO FEMORAL COMPONENT THROUGH THE METAPHYSIS. DOI: (B)(6) 2016, DOR: (B)(6) 2022, LEFT KNEE.

  Patient problems: Limb Fracture

  MAUDE report 14112148 ↗
• InjuryJul 21, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS A COLLAPSED TIBIAL COMPONENT AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENTS AT THE CEMENT TO IMPLANT INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2006, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Insufficient Information

  MAUDE report 12206549 ↗
• InjurySep 26, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. UNKNOWN CEMENT WAS USED. DOI: (B)(6) 2017; DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9123035 ↗
• InjuryApr 17, 2019Inadequacy of Device Shape and/or Size; Biocompatibility; Inadequacy of Device Shape and/or Size; Biocompatibility

  UPDATE 12 JUN 2019. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THERE IS NO ADDITIONAL INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISIONS. ON (B)(6) 2014, THE PATIENT UNDERWENT A LEFT KNEE ARTHROPLASTY DUE TO OSTEOARTHRITIS. THE SURGEON REPORTED NO INTRA-OPERATIVE COMPLICATIONS. ON (B)(6) 2015, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO A LOOSE FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE, PAIN, DISCOMFORT, INSTABILITY, WALKING DIFFICULTY, AND WEAKNESS. THE SURGEON REPORTED NO INTRA-OPERATIVE COMPLICATIONS. REVISION IS CAPTURED ON (B)(4). ON (B)(6) 2018, THE PATIENT UNDERWENT A LEFT KNEE REVISION. THE SECOND REVISION OPERATIVE NOTES WERE NOT AVAILABLE AT THE TIME OF REVIEW. REVISION IS CAPTURED ON (B)(4).

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 8522693 ↗
• InjuryNov 13, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  LITIGATION ALLEGES PAIN, DISCOMFORT, INSTABILITY AND DIFFICULTY AMBULATING CAUSED BY ASEPTIC LOOSENING DUE TO THE DEFECTIVE SMARTSET GHV BONE CEMENT. UPDATE: MEDICAL RECORDS RECEIVED (B)(6) 2018 WERE REVIEWED 13 NOV 2018 FOR MDR REPORTABILITY. IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THE FEMORAL COMPONENT WAS LOOSE AT THE IMPLANT/CEMENT INTERFACE.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Edema; Hypoesthesia; Joint Disorder; Muscular Rigidity; No Code Available; Pain; Weakness

  MAUDE report 8065762 ↗
• InjuryJan 29, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. ALL COMPONENTS REMOVED. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 7224355 ↗