LCS COMPLETE 1294-12-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10603295022923), received between Oct 11, 2018 and Jun 27, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loss of or Failure to Bond” (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 16, 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.

• InjuryJun 27, 2023Loss of or Failure to Bond; Loss of or Failure to Bond

  MEDICAL RECORDS AD (B)(6) 2023, WERE REVIEWED BY A CLINICIAN. PATIENT UNDERWENT A LEFT TOTAL KNEE ARTHROPLASTY UTILIZING DEPUY SYNTHES IMPLANTS ON (B)(6) 2013, INCLUDING PATELLA. COMPETITOR CEMENT WAS UTILIZED. ON (B)(6) 2023, THE PATIENT UNDERWENT A LEFT TOTAL KNEE REVISION FOR LOOSENING. DARK STAINING OF THE SYNOVIUM WAS PRESENT WITH EXTENSIVE METALLOSIS. THE FEMORAL COMPONENT WAS LOOSE WITH NO INTERFACE CLEARLY PROVIDED. THE TIBIAL COMPONENT WAS ALSO LOOSE AT THE IMPLANT TO CEMENT INTERFACE. THE PATELLA WAS UNDERSIZED ACCORDING TO THE SURGEON AND WAS REVISED. DOI: (B)(6) 2013. DOR: (B)(6) 2023. LEFT KNEE.

  Patient problems: Foreign Body Reaction; Synovitis

  MAUDE report 17208747 ↗
• InjuryJun 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT NONE OF THE IMPLANTS WERE REVISED. THE PATIENTS PATELLA WAS RESURFACED AND THE ECTOPIC BONE REMOVED. NONE OF THE KNEE COMPONENTS LISTED REQUIRED REVISION AND WERE ALL LEFT IN SITU. AS THIS WAS A REVISION PROCEDURE THERE WAS NO EXTENSION TO THE SURGICAL TIME.

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

  MAUDE report 12041158 ↗
• InjuryOct 23, 2019Loss of or Failure to Bond; Loss of or Failure to Bond

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT AT THE CEMENT TO IMPLANT INTERFACE. CEMENT MANUFACTURER WAS UNKNOWN. REVISED TO AN ATTUNE REVISION RP COMPONENT WITH SLEEVES AND STEMS AND TIBIAL WEDGE 15MM LEFT MEDIAL. DOI: (B)(6) 2009; DOR: (B)(6) 2019; LEFT KNEE.

  Patient problems: No Code Available; Pain

  MAUDE report 9227237 ↗
• InjuryOct 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL AND FEMORAL COMPONENT AT THE BONE TO CEMENT INTERFACE.

  Patient problems: No Code Available; Pain

  MAUDE report 7955941 ↗