OMNI Knee KC-36056Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690101772), received between Jul 7, 2021 and Nov 22, 2024 — 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.

• InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2013. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 20760702 ↗
• InjuryJul 24, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED. PER THE REP THE DR. CHOSE TO USE THE INSERT WITH NO BOLT AS A STAGE 1 PORTION OF THE REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 19815934 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION THE FEMUR, TIBIAL TRAY, PATELLA BUTTON, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS TO BE USED AS TEMPORARY SPACERS. ANOTHER SURGERY IS PLANNED IN 6 WEEKS TO PUT IN FINAL IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 15235632 ↗
• InjuryJul 7, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2019. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, THE PATELLA, TRIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12130653 ↗