LCS COMPLETE 1294-27-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10603295025368), received between Nov 21, 2018 and Mar 10, 2021 — classified as 8 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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 9 most recent of 9 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 11456153 ↗
• 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 11456054 ↗
• 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 9369505 ↗
• InjurySep 18, 2019Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL COMPONENT AT THE UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. SURGEON REMOVED THE LCS FEMUR AND FEMUR SLEEVE, REPLACED WITH A TC3 FEMUR WITH AUGMENTS, FEMUR SLEEVE, STEM AND NEW POLY. DOI: (B)(6) 2015. DOR: (B)(6) 2019, LEFT KNEE.

  Patient problems: No Code Available

  MAUDE report 9083245 ↗
• 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; UNKNWON JRN.

  Patient problems: No Code Available

  MAUDE report 8861808 ↗
• 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 8861807 ↗
• MalfunctionApr 24, 2019Difficult to Insert; Difficult to Insert

  IT WAS IMPOSSIBLE TO ATTACH THE 5MM STD+ AUGMENT TO THE FEMORAL COMPONENT. THEY TRIED TO ATTACH A STD 5MM AUGMENT ALSO, BUT IT WAS IMPOSSIBLE TO GET IT ATTACHED TO THE FEMUR. THEY IMPLANTED THE FEMUR WITHOUT AUGMENT AND WITH EXTRA CEMENT. OPENED ANOTHER IMPLANT, BUT WAS ALSO IMPOSSIBLE TO ATTACH. 20 MINUTE DELAY.

  Patient problems: Not Applicable

  MAUDE report 8544131 ↗
• 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 8094980 ↗
• 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 8094947 ↗