OMNI Knee KC-36041Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841690101673), received between Jan 31, 2018 and May 21, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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.

• InjuryMay 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE IS ON (B)(6) 2023. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

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

  MAUDE report 22060168 ↗
• InjuryOct 20, 2023Adverse 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) 2023 . THE ORIGINAL SURGERY DATE IS (B)(6) 2022. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 17974313 ↗
• InjuryOct 14, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Contracture

  MAUDE report 15607848 ↗
• InjuryNov 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 9386269 ↗
• InjuryAug 5, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED PATIENT INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 8861944 ↗
• InjuryJul 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION, THE TIBIAL INSERT, RETAINING BOLT AND TIBIAL BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall; Patient Problem/Medical Problem

  MAUDE report 8828071 ↗
• InjuryJan 29, 2019Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE FEMORAL COMPONENT, INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS AND ANTIBIOTIC CEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 8285380 ↗
• InjuryJan 14, 2019Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PAIN AND SWELLING. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain; Swelling

  MAUDE report 8246257 ↗
• InjuryJan 31, 2018Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY. DURING THE REVISION, THE OMNI INSERT WAS REVISED TO A NEW COMPONENT.

  Patient problems: No Code Available

  MAUDE report 7231729 ↗