LCS COMPLETE 1294-09-650Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295022657), received between Aug 18, 2017 and Sep 18, 2025 — classified as 13 injuries.

The most frequently reported specific device problem is “Naturally Worn” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2025Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LCS WAS STILL IMPLANTED DUE TO LENGTH OF IMPLANTATION PERIOD. POLYETHYLENE INLAY WORN THROUGH, MATERIAL WEAR DUE TO LONG WEARING TIME. PATIENT NEEDS CHANGE OF INLAY AND PATELLA.

  Patient problems: Insufficient Information

  MAUDE report 23082459 ↗
• InjuryJun 10, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE SURGEON HAD TO BRING BACK PATIENT FOR A REVISION PATELLA OF A LCS KNEE. THE POLY SHEARED OFF THE METAL BACKING. ORIGINAL IMPLANT (B)(6) 2022 TOTAL KNEE PROCEDURE. THERE WAS A REVISION OF PATELLA COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 22178291 ↗
• InjuryOct 15, 2024Naturally Worn; Naturally Worn

  IT WAS REPORTED A PATIENT HAS ANTERIOR KNEE PAIN AND THE POLY HAS BEEN INSITU FOR OVER 20 YEARS. THE DEVICE HAS WORN THROUGH AND NEEDS REPLACING. A CUSTOM POLY IS REQUIRED. A REVISION SURGERY WILL BE REQUIRED. INITIAL IMPLANT DATE WAS (B)(6) 2004.

  Patient problems: Pain

  MAUDE report 20449637 ↗
• InjuryApr 11, 2024Naturally Worn; Naturally Worn

  SUBJECT ID: (B)(6). STUDY NO: DOTS CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO POLY WEAR. DATE OF IMPLANT: (B)(6) 2011. DATE OF REVISION: (B)(6) 2024. (LEFT KNEE) . TREATMENT: PATELLA WAS REVISED.

  Patient problems: Insufficient Information

  MAUDE report 19089694 ↗
• InjuryOct 6, 2022Naturally Worn; Naturally Worn

  LCS COMPLETE POLY LINER AND PATELLA REVISION . IMPLANT CURRENTLY IN SITU HAD WEAR AND DELAMINATION ON BOTH IMPLANT COMPONENTS. PREVIOUS OPERATION WAS COMPLETE IN 2011. PATIENT EXPERIENCED PAIN DUE TO WEAR ON POLY AND PATELLA. REVISION TOOK PLACE ON (B)(6) 2022. NEW TIBIAL INSERT AND PATELLA PUT IN. DOI: (B)(6) 2011. DOR: (B)(6) 2022. UNKNOWN SIDE.

  Patient problems: Pain

  MAUDE report 15554865 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. ORIGINAL IMPLANT DATE IS UNKNOWN. DOI: UNKNOWN, DOR: (B)(6) 2020, LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 10621962 ↗
• InjuryAug 19, 2019Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE PATELLA AT THE BONE TO IMPLANT INTERFACE. THE PATELLA WAS REPLACED WITH A DOME PATELLA. DOI: (B)(6) 2009; DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: Inadequate Osseointegration; No Code Available

  MAUDE report 8907492 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION TKR - EXCISION OF OSTEOPHYTE/ ECTOPIC BONE, CAUSING ANTERIOR KNEE PAIN.

  Patient problems: No Code Available; Pain

  MAUDE report 8536469 ↗
• InjuryApr 8, 2019Loss of Osseointegration; Loss of Osseointegration

  REVISION DUE TO PAIN AND LOOSENING OF THE PATELLA.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8490984 ↗
• InjuryMar 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT ORTHOPEDIC SURGERY ON OR ABOUT (B)(6), 2017 AND (B)(6), 2017, AND WAS IMPLANTED WITH DEPUY SYNTHES DEVICES WHICH SUBSEQUENTLY MALFUNCTIONED OR FAILED, CAUSING PLAINTIFF INJURIES, DEBILITATION AND NECESSITATING FURTHER MEDICAL INTERVENTIONS.

  Patient problems: Injury; No Code Available; Pain

  MAUDE report 8448017 ↗
• InjuryFeb 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ORIGINAL IMPLANT DATE WAS UNKNOWN, THE PATIENT HAD PAIN IN HER PATELLA. THE SURGEON REMOVED A STD + METAL BACKED PATELLA OUT AND PUT A LARGE LOW PROFILE PATELLA BACK IN. SURGEON ADVISED THAT THEY SHOULD TRY TO MATCH THE FEMUR WITH THE PATELLA SIZE. HE DECIDED HE NEEDED MORE COVERAGE AND WENT LARGER. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8370995 ↗
• InjuryMay 14, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  REVISION KNEE; DR (B)(6), (B)(6) HOSPITAL (B)(6) 2018. TIBIAL INSERT AND PATELLA INSERT CHANGED FOR AN INFECTED KNEE WITH WOUND BREAKDOWN. PATIENT HAD ORIGINAL KNEE REPLACEMENT 6 WEEKS AGO. ACTUAL OPERATION DATE UNKNOWN, NO X-RAY'S OR PATIENT NOTES AVAILABLE. FEMALE PATIENT INITIALS: (B)(6), AGED (B)(6) YEARS, DOB:(B)(6), WEIGHT: (B)(6), HEIGHT: (B)(6) DOI: 6 WEEKS AGO; DOR: (B)(6) 2018 UNKNOWN KNEE.

  Patient problems: Not Applicable; Unspecified Infection

  MAUDE report 7511069 ↗
• InjuryAug 18, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAIN AND STIFFNESS.

  Patient problems: Muscular Rigidity; Pain

  MAUDE report 6805289 ↗