LCS COMPLETE 1294-02-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295021629), received between Dec 19, 2017 and Mar 15, 2022 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryMar 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 13769672 ↗
• InjuryNov 1, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT REVISED DUE TO LOOSE LEFT FEMORAL COMPONENT. ORIGINAL DOS 2006. DOI: 2006, DOR: (B)(6) 2021, LEFT SIDE.

  Patient problems: Pain

  MAUDE report 12728296 ↗
• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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 12480938 ↗
• InjuryNov 24, 2020Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  PT LEFT TKR - LCS 2017 AT (B)(6). PT IV HEROIN USER/FELL/INFECTION. LEAD TO REVISION OF SUBLAXED TIBIAL COMPONENT. FIRST STAGE CARRIED OUT ONLY - DUE TO INFECTION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Fall; Joint Laxity; Pain

  MAUDE report 10892810 ↗
• InjuryAug 4, 2020Use of Device Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  WAS THE KNEE MALPOSITIONED TO OFFSET THE PATIENT'S ANATOMY? OR WAS IT JUST NOT PUT IN CORRECTLY? ANSWER: THE REVISING SURGEON SUSPECTED THE TIBIAL RESECTION HAD BEEN CUT AT THE INCORRECT ANGLE CAUSING THE ISSUE. WAS THERE MALPOSTIONING OF ALL THE KNEE COMPONENTS? OR JUST SPECIFICALLY THE TIBIAL TRAY? ANSWER: DUE TO THE LCS SURGICAL TECHNIQUE, THIS ALSO RESULTED IN A SLIGHT ROTATIONAL ISSUE WITH THE FEMUR.

  Patient problems: Discomfort; No Code Available

  MAUDE report 10362912 ↗
• MalfunctionOct 11, 2018Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT WHEN OPENING THE PROTECTIVE COVER ON THE TOP OF THE IMPLANT, PART OF THE COVERING TORE AND CUT A PORTION OF THE COVER STILL ON THE PLASTIC CARRIER. THIS KEPT THE IMPLANT FROM BEING REMOVED FROM THE PLASTIC CONTAINER. THE SURGEON TRIED TO PULL THE TAB ON THE IMPLANT AND TORE IT TOO. AFTER THIS, THE SURGEON DID NOT FEEL HE COULD TRANSFER THE IMPLANT ONTO THE STERILE FIELD SAFELY. HE DID NOT WANT TO CONTAMINATE THE FIELD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7956026 ↗
• InjuryFeb 14, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  REVISION LCS, SURGEON - (B)(6), (B)(6) HOSPITAL (B)(6) 2018. REVISED FOR FEMORAL LOOSENING, TIBIA IN SLIGHT VARUS. RELEVANT PATIENT PRE-EXISTING CONDITIONS: OBESE AS PER BMI CALCULATIONS. FEMALE PATIENT, INITIALS (B)(6), AGED (B)(6) YEARS, DOB: (B)(6). UNKNOWN JRN: STD LEFT LCS FEMUR, STD 10 MM POLY, 2.5 DUOFIX TIBIA. DOI:UNKNOWN; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7269371 ↗
• InjuryDec 19, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  THE PATIENT WAS REVISED FOR PAIN.

  Patient problems: Pain

  MAUDE report 7128295 ↗