OMNI Knee KC-35020Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841690101208), received between Feb 8, 2017 and Sep 28, 2021 — classified as 9 injuries.

The most frequently reported specific device problem is “Unstable” (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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2021Unstable; 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) 2021. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 12542466 ↗
• InjuryMar 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS POSSIBLE INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8416927 ↗
• InjuryJan 3, 2019Appropriate 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 OF POSSIBLE INFECTION. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8212214 ↗
• InjuryJul 6, 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) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 LEFT CR FEMORAL COMPONENT, SIZE 2 X 10MM CONGRUENT INSERT, TIBIAL BASEPLATE RETAINING BOLT, SIZE 3 LEFT TIBIAL BASEPLATE, AND 35X8MM PATELLA DOME WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 7667482 ↗
• InjuryJul 6, 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 X 10MM CR CONGRUENT INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 2 X 10MM CS ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: Unspecified Infection

  MAUDE report 7667479 ↗
• InjuryJun 29, 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 2 X 10MM CONGRUENT INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 2 X 12MM ULTRA CS TIBIAL INSERT AND TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7652759 ↗
• InjuryJan 31, 2018Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 X 10MM INSERT WAS REVISED AND REPLACED WITH A SIZE 2 X 12MM INSERT.

  Patient problems: No Code Available

  MAUDE report 7231724 ↗
• InjuryNov 22, 2017Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THIS REVISION, ALL ORIGINAL OMNI IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 7053878 ↗
• InjuryFeb 8, 2017Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2009. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY IN THE KNEE AND POSSIBLE PATIENT FALL. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REVISED. THE ORIGINAL SIZE 2 X 10 MM INSERT AND RETAINING BOLT WERE REVISED TO A SIZE 2 X 14 MM INSERT AND RETAINING BOLT.

  Patient problems: Fall

  MAUDE report 6312685 ↗