OMNI Knee KC-35022Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690101222), received between Mar 18, 2020 and Jun 8, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 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 11/20/2021. THE REASON FOR REVISION IS REPORTED TIGHT JOINT. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT WAS REMOVED AND REPLACED WITH NEW IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 14632483 ↗
• InjuryAug 26, 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 12369813 ↗
• InjuryMar 18, 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 DATE IS (B)(6) 2010. DURING THE REVISION A POLY SWAP OCCURRED REPLACING THE TIBIAL INSERT AND RETAINING BOLT.

  Patient problems: No Code Available

  MAUDE report 9850193 ↗