SIGMA LCS COMPLETE POROCOAT 1294-34-140Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295025887), received between Mar 1, 2018 and Oct 19, 2023 — classified as 8 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 19, 2023Osseointegration Problem; Osseointegration Problem

  PATIENT WAS REVISED DUE TO PAIN AND LOOSENING OF THE FEMUR AND TIBIA AT BONE TO IMPLANT INTERFACE. CEMENT MANUFACTURER IS DEPUY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Inadequate Osseointegration; Pain

  MAUDE report 17967535 ↗
• InjuryApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. REMOVAL OF ALL COMPONENTS. DATE OF IMPLANT: (B)(6) 2016. DATE OF IMPLANT (INSERT): (B)(6) 2022, DATE OF REVISION: (B)(6) 2022, (RIGHT KNEE).

  Patient problems: Unspecified Infection

  MAUDE report 14193982 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR LATERAL ABSCESS. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS NOT RELATED TO DEVICE AND POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2009, DATE OF IMPLANT INSERT: (B)(6) 2016, DATE OF EVENT: (B)(6) 2022, (RIGHT KNEE). TREATMENT: IRRIGATION AND DEBRIDEMENT.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 14083842 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, RIGHT KNEE.

  Patient problems: Pain

  MAUDE report 12533816 ↗
• InjuryDec 13, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO FLEXION CONTRACTURE AND STABILITY ISSUES. ALL COMPONENTS WERE REMOVED AND ATTUNE REVISION COMPONENTS WERE IMPLANTED. THE LOT NUMBERS ON THESE EXPLANTED COMPONENTS WERE NOT LEGIBLE EXCEPT FOR THE POLYETHYLENE BEARING. POROCOATED IMPLANTS WERE USED. DOI: UNKNOWN. DOR: (B)(6) 2019. RIGHT KNEE.

  Patient problems: No Code Available

  MAUDE report 9467169 ↗
• InjuryJan 31, 2019Loss of Osseointegration; Loss of Osseointegration

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

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8292703 ↗
• InjuryNov 13, 2018Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIAL COMPONENT AT NON-CEMENTED INTERFACE.

  Patient problems: Inadequate Osseointegration; No Code Available; Pain

  MAUDE report 8064043 ↗
• InjuryMar 1, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  THE PATIENT WAS REVISED TO ADDRESS PAIN AND LOOSENING OF THE TIBIA AT THE BONE TO IMPLANT INTERFACE AND PATELLA AT THE UNKNOWN INTERFACE. DEPUY CEMENT WAS USED. DOI: (B)(6) 2005, DOR: (B)(6) 2018, RIGHT SIDE.

  Patient problems: Inadequate Osseointegration

  MAUDE report 7306083 ↗