LCS COMPLETE 1294-09-540Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295022572), received between Sep 28, 2020 and Aug 16, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• 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 15232825 ↗
• InjuryJun 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INSTABILITY. SURGEON CLAIMED THE PRIMARY IMPLANT FEMORAL JOINT LINE WAS RAISED. NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: Joint Laxity; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877429 ↗
• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF LCS REVISION BECAUSE OF PAIN AND STIFFNESS - REVISED TO A HINGE FROM ANOTHER COMPANY. DOI: (B)(6) 2019. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13757633 ↗
• InjurySep 16, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT PRIMARY LEFT IMPLANTS ON (B)(6) 2020. SHE HAD AN I&D AND REPLACEMENT OF POLY ON (B)(6) 2020 ((B)(4)). THIS PATIENT IS VERY SICK WITH MULTIPLE COMORBIDITIES. SHE HAD AN ABSCESS ON THE LEFT KNEE SURGICAL SITE. THERE WAS NOTICEABLE ASEPTIC LOOSENING OF THE FEMORAL AND PATELLA COMPONENTS. ALL IMPLANTS WERE REMOVED WITH NO PLAN TO REIMPLANT. SURGEON PERFORMED AN END-STAGE ARTHRODESIS. HER RIGHT KNEE WAS PERFORMED YEARS AGO AND SEEMS TO BE UNAFFECTED. DOI: (B)(6) 2021. DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 12480939 ↗
• InjuryApr 9, 2021Off-Label Use; Use of Device Problem; Off-Label Use; Use of Device 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 11640672 ↗
• 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 10595777 ↗