LCS COMPLETE 1294-05-617Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295022183), received between May 24, 2019 and Sep 16, 2021 — classified as 4 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS LOOSENING OF THE FEMORAL AND TIBIAL COMPONENTS AT THE BONE TO CEMENT AND CEMENT TO IMPLANT INTERFACES. UNKNOWN BONE CEMENT WAS USED. OSTEOLYSIS WAS ALSO NOTED. DOI: 2000, DOR: (B)(6), 2021, RIGHT KNEE.

  Patient problems: Osteolysis

  MAUDE report 12485951 ↗
• InjuryMar 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DAIR PROCEDURE (BEARING CHANGE AND WASHOUT) OF LEFT LCS TKR INVOLVING REVISION PROSTHESIS DETAILS UNKNOWN. THE PROCEDURE APPEARS TO BE ON A PREVIOUSLY REVISED TKR. SALES REP DID NOT ATTEND THE CASE AND HAD LIMITED KNOWLEDGE OF THE CASE AND ANY DETAIL EXCEPT THAT THE BEARING WAS REMOVED AND THE KNEE WASHOUT FOR INFECTION. THE IMPLANT HAD STEMS ATTACHED TO MODULAR REVISION LCS FEMUR AND MBT RP TIBIA BUT NO ACTUAL DETAILS.

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

  MAUDE report 11486124 ↗
• InjuryJan 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS MCL DEFICIENT. ORIGINAL IMPLANT DATE UNKNOWN. NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2021; LEFT KNEE.

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

  MAUDE report 11212881 ↗
• InjuryMay 24, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND INSTABILITY. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 8639944 ↗