LCS COMPLETE 1294-05-615Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295022176), received between May 4, 2018 and Oct 25, 2022 — classified as 9 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 18, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED KNEE AND LOOSENING OF THE TIBIAL COMPONENT AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. ALL IMPLANTS REMOVED. NO FURTHER INFORMATION IS AVAILABLE. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15666302 ↗
• InjuryAug 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHANGED LCS IMPLANTS FOR INFECTION. IT WAS UNKNOWN IF ANY LOOSENING. IT WAS UNKNOWN IF ANY SURGICAL DELAY REPORTED. DOI: (B)(6) 2019; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 15282315 ↗
• InjuryDec 23, 2021Naturally Worn; Naturally Worn

  REVISION COMPLETED TO ADDRESS PAIN. PATELLA RESURFACING AND SOFT TISSUE RELEASE WERE COMPLETED. INSERT WAS REMOVED. INSERT WAS WORN.

  Patient problems: Pain

  MAUDE report 13078528 ↗
• InjuryDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN. DOR: (B)(6) 2021, LEFT KNEE.

  Patient problems: Pain

  MAUDE report 12934325 ↗
• InjuryMay 6, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. DOI: (B)(6) 2018. DOR: (B)(6) 2020; RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 10028901 ↗
• InjuryApr 16, 2019Naturally Worn; Naturally Worn

  MINOR REVISION OF LCS TOTAL KNEE REPLACEMENT. ORIGINAL SURGERY WAS (B)(6) 2009. PATIENT PRESENTED TO SURGEON WITH PROGRESSION OF ARTHRITIS TO PATELLA WHICH WAS NOT RESURFACED AT THE TIME OF ORIGINAL SURGERY. PATIENT WAS ALSO EXPERIENCING SWELLING AND PAIN. SOME LYSIS WAS OBSERVED ON XRAY. SURGEON PERFORMED REVISION SURGERY TO RESURFACE THE PATELLA, TAKE SPECIMENS FOR PATHOLOGY AND EXCHANGE THE TIBIAL INSERT. ORIGINAL INSERT WAS REMOVED AND SOME MINOR POLY WEAR WAS OBSERVED. SPECIMENS WERE TAKEN, A TRIAL INSERT WAS PLACED TO CONFIRM APPROPRIATE JOINT STABILITY, AND THEN THE PATELLA WAS RESECTED AND PREPARED FOR RESURFACING. A NEW LARGE 15MM LCS INSERT AND LARGE ALL-POLY PATELLA WERE IMPLANTED AND THE WOUND WAS WASHED OUT WITH PULSE LAVAGE AND CLOSED. PATIENT STATUS/OUTCOME/CONSEQUENCES: NO, WAS OTHER MEDICAL INTERVENTION (E.G. X-RAYS, ADDITIONAL PROCEDURES, PRESCRIPTIONS, OTC, REVISION) REQUIRED: NO.

  Patient problems: No Code Available; Osteolysis; Pain; Swelling

  MAUDE report 8520061 ↗
• InjuryDec 19, 2018Naturally Worn; Naturally Worn

  THE PATIENT WAS REVISED DUE TO CHRONIC JOINT EFFUSION. THE CENTRAL PART OF THE BEARING EXHIBITED WEAR AND APPEARED TO BE RUBBING ON THE PATIENT'S TISSUE IN THE AREA OF THE FEMORAL NOTCH. THE POLY INSERT AND POLY PATELLA WERE REVISED.

  Patient problems: No Code Available

  MAUDE report 8178823 ↗
• InjuryAug 17, 2018Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD DISTAL FEMUR FRACTURE THAT WAS TREATED WITH RETROGRADE NAIL IN 2017. THE NAIL WAS PROMINENT AND CAUSED PAIN AND NOTCHING OF THE POLY.DOI: (B)(6) 2004; DOR: (B)(6) 2018; LEFT KNEE.

  Patient problems: Discomfort; Not Applicable; Pain

  MAUDE report 7792594 ↗
• InjuryMay 4, 2018Migration or Expulsion of Device; Device Dislodged or Dislocated; Migration or Expulsion of Device; Device Dislodged or Dislocated

  DER STATES THAT THE PATIENT HAD A LCS TOTAL KNEE REPLACEMENT. THE TIBIAL INSERT LATER SPUN AND DISLOCATED. SURGEON REVISED DUE TO WHAT HE DETERMINED TO BE AN INADEQUATE BALANCE BETWEEN THE FLEXION AND EXTENSION GAPS. THE FEMORAL COMPONENT AND TIBIAL INSERT WERE REMOVED AND IT WAS REVISED USING THE PFC SIGMA REVISION SYSTEM. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT KNEE.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7486653 ↗