OMNI Knee KC-36034Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00841690101628), received between May 18, 2017 and Feb 10, 2021 — classified as 11 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 10, 2021Loose or Intermittent Connection; Appropriate 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 REPORTED MECHANICAL LOOSENING FROM BONE TO NON-OMNI CEMENT. DURING THE REVISION THE ORIGINAL TIBIAL INSERT, RETAINING BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 11311967 ↗
• InjuryJan 15, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2017. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REMOVED ORIGINAL TIBIAL INSERT AND RETAINING BOLT AND REPLACED THEM WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 11182404 ↗
• InjuryDec 16, 2020Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11017110 ↗
• InjuryAug 11, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2019. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT CONDITION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10393284 ↗
• InjuryMar 31, 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 (B)(6) 2016. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND FEMORAL COMPONENT WERE REVISED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9907825 ↗
• InjuryMar 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) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED POOR RANGE OF MOTION/STIFF KNEE. DURING THE REVISION, THE APEX ULTRA KNEE AND RETAINING BOLT WERE REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Loss of Range of Motion

  MAUDE report 9874746 ↗
• InjuryDec 12, 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) 2015. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS

  Patient problems: Fall

  MAUDE report 9459434 ↗
• InjuryDec 3, 2019Improper or Incorrect Procedure or Method

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE SURGERY ON (B)(6) 2019. DURING THE SURGERY, AN EXPIRED IMPLANT WAS IMPLANTED INTO THE PATIENT.

  Patient problems: No Code Available

  MAUDE report 9403829 ↗
• InjurySep 28, 2017Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2013. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN AND INSTABILITY. DURING THIS REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 6901174 ↗
• InjuryJul 13, 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 IN THE KNEE. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X 14 MM INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 X 18 MM INSERT AND RETAINING BOLT.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6710678 ↗
• InjuryMay 18, 2017Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY IN THE KNEE. DURING THE REVISION, THE ORIGINAL SIZE 3 X 14 MM TIBIAL INSERT AND RETAINING BOLT WAS REVISED TO A SIZE 3 X 18 MM TIBIAL INSERT AND RETAINING BOLT.

  Patient problems: Complaint, Ill-Defined; Failure of Implant

  MAUDE report 6576426 ↗