LCS COMPLETE 1294-02-060Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295021643), received between Aug 25, 2017 and Feb 22, 2023 — classified as 12 injuries, 2 malfunctions.

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

• InjuryFeb 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND CONFIRMED THAT THERE WERE NO SURGICAL DELAYS.

  Patient problems: Foreign Body Reaction; Inflammation; Pain

  MAUDE report 16417028 ↗
• InjuryJul 20, 2021Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE UNKNOWN COMPONENT AT THE BONE TO CEMENT & CEMENT TO IMPLANT INTERFACES. COMPETITOR CEMENT WAS USED. DOI: (B)(6) 2011 DOR: (B)(6) 2021; LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12196436 ↗
• InjuryMay 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE KNEE HAD A 40 DEGREE CONTRACTURE AND WAS TIGHT. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Joint Contracture; Loss of Range of Motion; Muscular Rigidity

  MAUDE report 11858248 ↗
• InjuryMar 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH AN INFECTED TOTAL KNEE, SURGEON ELECTED TO REMOVE ALL IMPLANTS AND PERFORM AN ANTIBIOTIC SPACER. NO DELAY TO SURGERY REPORTED. DOI: (B)(6) 2020, DOR: (B)(6) 2021, LEFT KNEE.

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

  MAUDE report 11544475 ↗
• InjuryApr 7, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. DOI: UNKNOWN; DOE: (B)(6) 2020; LEFT KNEE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9933343 ↗
• InjuryAug 20, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT HAS BEEN COMPLAINING OF "STIFFNESS AND LOSS OF FUNCTION" OVER THE LAST 6 TO 8 MONTHS. FOLLOWING INVESTIGATIONS, BLOODS AND SCANS DIDN'T SEEM TO INDICATE INFECTION, BUT COMPONENTS WERE SUSPECTED TO BE LOOSE. REVISION SURGERY WAS PERFORMED, AND BOTH FEMUR AND TIBIA WERE LOOSE (FAILURE WAS A COMBINATION OF IMPLANT/CEMENT AND CEMENT/BONE INTERFACES - PALACOS BONE CEMENT WAS USED IN THE ORIGINAL CASE). KNEE WAS REVISED TO AN ATTUNE REVISION KNEE SYSTEM. PATIENT STATUS/ OUTCOME / CONSEQUENCES: YES.

  Patient problems: Joint Disorder; Loss of Range of Motion; No Code Available; Pain

  MAUDE report 8910892 ↗
• InjuryMar 18, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE FEMORAL AND TIBIAL COMPONENT AT CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS UNKNOWN. DOI: (B)(6) 2004; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8429271 ↗
• MalfunctionSep 24, 2018Packaging Problem; Packaging Problem

  THE 'LIFT HERE' STERILE TABS ON THE PACKAGING TORE OFF (TIBIAL TRAY) AND STARTED TO TEAR AWAY (FEMORAL COMPONENT) (AS LISTED ABOVE) WHEN LIFTING THE IMPLANTS FROM THE NON-STERILE PACKAGING WITH ARTERY FORCEPS WITH THE 'LIFT HERE' TAB. STERILE FIELD WAS NOT COMPROMISED AND NO ISSUE OR DELAY IN PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902436 ↗
• MalfunctionSep 24, 2018Device Damaged by Another Device; Packaging Problem

  THE 'LIFT HERE' STERILE TABS ON THE PACKAGING TORE OFF (TIBIAL TRAY) AND STARTED TO TEAR AWAY (FEMORAL COMPONENT) (AS LISTED ABOVE) WHEN LIFTING THE IMPLANTS FROM THE NON-STERILE PACKAGING WITH ARTERY FORCEPS WITH THE 'LIFT HERE' TAB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7902404 ↗
• InjuryJul 20, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  REVISION TOTAL KNEE REPLACEMENT; DR (B)(6); (B)(6) ON (B)(6) 2018 - PATIENT UNDERWENT PRIMARY TKR ON (B)(6) 2016 WHERE AN LCS COMPONENT WAS IMPLANTED (DR (B)(6), (B)(6) HOSPITAL). PATIENT WAS DOING WELL UNTIL APPROXIMATELY 12 MOTHS POST SURGERY WHEN HE DESCRIBES "SOMETHING HAPPENED". FOLLOWING THIS INCIDENT HIS KNEE HAS BECOME PROGRESSIVELY MORE PAINFUL. X RAYS SHOW THE FEMORAL COMPONENT HAS COME LOOSE AND IS SITTING IN A FLEXED POSITION. THERE ALSO APPEARS TO BE LUCENT LINES UNDER THE TIBIAL COMPONENT. A DECISION WAS MADE TO REVISE THE KNEE - DR (B)(6), (B)(6) ON (B)(6) 2018. ON OPENING THE KNEE THE FEMORAL COMPONENT WAS LOOSE. THERE APPEARED TO BE DEBONDING AT THE CEMENT IMPLANT INTERFACE. THE SURGEON COMMENTED THAT THIS MAY HAVE BEEN A RESULT OF HIS CEMENT TECHNIQUE WHICH HE HAS NOW MODIFIED. THE TIBIAL COMPONENT WAS RELATIVELY WELL FIXED. ALL COMPONENTS WERE REMOVED AND A PFC TC3 RP WITH SLEEVES ON BOTH THE FEMUR AND TIBIA IMPLANTED. MALE PATIENT INITIALS (B)(6).

  Patient problems: Pain

  MAUDE report 7707494 ↗
• InjuryApr 11, 2018Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT THE CEMENT TO IMPLANT INTERFACE, DEPUY CEMENT WAS USED. THE FEMUR, INSERT, AND PATELLA WERE REVISED. DOI: (B)(6) 2014; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: No Known Impact Or Consequence To Patient; Not Applicable

  MAUDE report 7420935 ↗
• InjuryNov 20, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMUR AT THE BONE TO CEMENT INTERFACE. DEPUY CEMENT WAS USED. UPDATE 10-26-2017. MEDICAL RECORDS REVIEWED. PRIMARY OPERATIVE NOTES (B)(6) 2013 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REPLACEMENT DUE TO OSTEOARTHRITIS OF THE LEFT KNEE. PROCEDURE WAS COMPLETED WITHOUT COMPLICATION NOTED BY THE SURGEON. OFFICE NOTES (B)(6) 2017 INDICATE THE PATIENT PRESENTS DUE TO KNEE PAIN AS WELL AS A FEELING OF INSTABILITY AND POPPING. REVISION NOTES (B)(6) 2017 INDICATE THE PATIENT RECEIVED A LEFT TOTAL KNEE REVISION ARTHROPLASTY WITH REPAIR OF EXTENSOR MECHANISM TO THE PATELLA DUE TO FAILED TOTAL KNEE ARTHROPLASTY WITH LOOSENING OF THE FEMORAL COMPONENT. UPON ENTERING THE JOINT, THE SURGEON NOTES THE PATELLA ITSELF WAS DETACHED FROM THE PROXIMAL PORTION OF THE EXTENSOR MECHANISM AND ATTACHED ON DISTALLY TO THE PATELLAR TENDON. THE PATELLA, ASIDE FROM THE DISTAL POLE, WAS COMPLETELY LOOSENED FROM THE EXTENSOR MECHANISM AND QUADRICEPS TENDON AND SOME SMALL REMNANT OF THE PATELLA WERE NOTED PROXIMALLY. PRESUMABLE WERE FRACTURES THAT OCCURRED. THE PATELLA COMPONENT ITSELF WAS NOT LOOSE, THERE WAS EVIDENCE OF NECROSIS OF THE BONE AROUND THE SUPER

  Patient problems: Bone Fracture(s); Necrosis; No Code Available; Pain; Swelling

  MAUDE report 7045826 ↗
• InjuryOct 5, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 6917388 ↗
• InjuryAug 25, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF FEMORAL COMPONENT AT THE BONE TO IMPLANT INTERFACE.

  Patient problems: No Code Available

  MAUDE report 6820091 ↗