OMNI Knee KC-40298Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690101932), received between Mar 27, 2020 and Nov 22, 2023 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 22, 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 IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED PATELLA LOOSENING. DURING THE REVISION THE ORIGINAL PATELLA BUTTON INSERT, WAS REMOVED AND REPLACED WITH NEW IMPLANT, ALL OTHER ORIGINAL IMPLANTS LEFT IN SUTI.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18197036 ↗
• InjuryMay 9, 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 IS DATED (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATELLAR LOOSENING. DURING THE REVISION THE ORIGINAL PATELLA WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 11795583 ↗
• InjuryFeb 19, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REVISION SURGERY OCCURRED BECAUSE OF A LOOSE PATELLA. DURING THE REVISION, THE PATELLA IMPLANT WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 11347867 ↗
• InjuryMar 27, 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 IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION DR REPLACED THE PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 9889922 ↗