LCS COMPLETE 1294-28-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295025467), received between Jul 19, 2017 and Mar 10, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Fracture” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED. DOI: (B)(6) 2019. DOR: (B)(6) 2021. RIGHT KNEE.

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

  MAUDE report 11455973 ↗
• InjuryNov 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS UNSTABLE LCS. REVISED ONLY THE FEMUR AND LINER, WHILE KEEPING THE TIBIA COMPONENTS. ALSO REMOVED THE PATELLA COMPONENT. DOI: (B)(6) 2014; DOR: (B)(6) 2019 RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9369498 ↗
• InjuryAug 5, 2019Use of Device Problem; Malposition of Device; Use of Device Problem; Malposition of Device

  PRIMARY IMPLANTED ON (B)(6) 2012. REASON FOR REVISION: MALALIGNMENT. PATIENT HAD THE ABOVE IMPLANTS IN SITU. TKJR REVISION PERFORMED AS IMPLANTS MALALIGNED AND OSTEOLYSIS PRESENT. NO FURTHER COMMENT FROM SURGEON. IMPLANTS REMOVED, SPECIMENS TAKE TO RULE OUT INFECTION. J&J REP WAS PRESENT AT THE CASE. TC3 IMPLANTS IMPLANTED. IMPACTED PRODUCTS: 1 X D129424520 ;LCS COMP VVC INS STD+ 20MM; LOT NO: UNKNOWN; 1 X LCS STD + FEMUR -UNKNOWN JRN; 1 X D129435130C ; MBT REVISION CEM TIB TRAY SZ 3 ; LOT NO: FH8JL1; 1 X D11082083; UNKNOWN JRN.

  Patient problems: No Code Available

  MAUDE report 8861804 ↗
• InjuryJan 11, 2019Noise, Audible; Noise, Audible

  PATIENT WAS REVISED DUE TO REDUCED MOVEMENT AND AN 'AUDIBLE CLUNK' DURING RANGE OF MOTION.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 8239713 ↗
• InjuryNov 21, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED TO ADDRESS PAIN.

  Patient problems: Pain

  MAUDE report 8095009 ↗
• InjuryAug 4, 2017Fracture; Fracture

  REVISION OF VVC PROSTHESIS RIGHT SIDE BECAUSE OF FRACTURE OF MEDIAL CONDYLE.

  Patient problems: No Information

  MAUDE report 6766446 ↗
• InjuryJul 19, 2017Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS INSTABLITY AND LOOSENING.

  Patient problems: No Information

  MAUDE report 6724850 ↗