OMNI Knee KC-35041Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841690101314), received between Nov 29, 2017 and Jan 23, 2025 — classified as 10 injuries.

The most frequently reported specific device problem is “Unstable” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 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 (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Pain

  MAUDE report 21218804 ↗
• InjurySep 19, 2024Patient Device Interaction Problem; Patient Device Interaction 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) 2016. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 20255885 ↗
• InjuryNov 4, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  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, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 15736515 ↗
• InjuryJul 11, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 14980998 ↗
• InjuryAug 20, 2021Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2020. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12348529 ↗
• InjuryAug 18, 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) 2020. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, BASEPLATE, PATELLA, FEMUR WERE REMOVED AND REPLACED WITH NEW NON OMNI COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12339325 ↗
• InjuryNov 19, 2020Unstable

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2016. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, PATELLA AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

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

  MAUDE report 10872830 ↗
• InjuryAug 27, 2018Unstable

  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 INSTABILITY DUE TO A REPORTED PATIENT FALL. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 11MM CONGRUENT INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 4 X 12MM CONGRUENT INSERT AND ANOTHER TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: Fall

  MAUDE report 7817827 ↗
• InjuryJun 6, 2018Adverse 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF AN INFECTION, AS REPORTED. DURING THE REVISION, THE ORIGINAL OMNI DOVETAIL INSERT LOCKING CONNECTOR AND DOVETAIL CONGRUENT INSERT, SZ 4, 11MM WAS REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7575331 ↗
• InjuryNov 29, 2017Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY. DURING THIS REVISION, THE ORIGINAL OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND EXCHANGED FOR THICKER COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 7069158 ↗