OMNI Knee KC-35040Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00841690101307), received between Mar 10, 2017 and Feb 12, 2025 — classified as 17 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 12, 2025Appropriate 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 UNKNOWN. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH IMPLANTS.

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

  MAUDE report 21366352 ↗
• InjuryFeb 11, 2025Adverse 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) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2017. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE PATELLA, TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 21358031 ↗
• InjuryAug 9, 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) 2021. 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 15191090 ↗
• InjuryJun 9, 2022Unstable

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED INSTABILITY AND HYPEREXTENSION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

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

  MAUDE report 14642905 ↗
• InjuryMar 18, 2022Loose or Intermittent Connection

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

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

  MAUDE report 13803858 ↗
• InjuryJan 4, 2022Appropriate 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) 2021. 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 13157686 ↗
• InjuryMar 27, 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 OCCURRED ON (B)(6) 2020, THE REASON FOR REVISION IS REPORTED PATIENT SCAR TISSUE. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Scar Tissue

  MAUDE report 11579886 ↗
• InjuryMar 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 SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11521452 ↗
• InjuryJun 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: No Code Available

  MAUDE report 10171219 ↗
• InjuryJun 2, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS UNKNOWN. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION HAD TO BREAK UP SCAR TISSUE SO THEY SWAPPED OUT FOR NEW POLY.

  Patient problems: Pain

  MAUDE report 10112413 ↗
• InjuryJan 24, 2020Insufficient 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 TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9629797 ↗
• InjuryOct 3, 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) 2011. THE REASON FOR REVISION WAS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED FOR LARGER COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 9152736 ↗
• InjuryOct 3, 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) 2010. THE REASON FOR REVISION WAS REPORTED PATIENT PAIN. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REVISED TO NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Pain

  MAUDE report 9152734 ↗
• InjuryNov 9, 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 REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 10MM INSERT AND BOLT WERE REVISED TO A SIZE 4 X 12MM INSERT AND BOLT.

  Patient problems: No Information

  MAUDE report 8056663 ↗
• 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 10MM CONGRUENT INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 4 X 14MM ULTRA INSERT AND ANOTHER TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817869 ↗
• InjuryJun 21, 2018Appropriate 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE IT WAS REPORTED THAT THE PATIENT DEVELOPED BLOOD CLOTS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4X10MM CONCRUENT INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH COMPONENTS OF THE SAME SIZE.

  Patient problems: Thrombus

  MAUDE report 7626225 ↗
• InjuryMar 10, 2017Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT STIFFNESS AND ARTHROFIBROSIS. DURING THE REVISION, THE ORIGINAL SIZE 4 X 10MM INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS.

  Patient problems: No Information

  MAUDE report 6395122 ↗