OMNI Knee KC-35032Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841690101277), received between Feb 6, 2017 and Sep 7, 2022 — classified as 10 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 7, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED 7/10/2013. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 15371268 ↗
• InjuryNov 26, 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) 2020. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 10909946 ↗
• InjuryJan 28, 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, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 9638771 ↗
• InjuryFeb 11, 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8325649 ↗
• InjuryOct 22, 2018Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON THE REVISION OCCURED IS REPORTED INSTABILITY. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REVISED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 7989738 ↗
• InjurySep 28, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A FIFTH KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY WAS (B)(6) 2014, FIRST REVISION (B)(6) 2015, SECOND (B)(6) 2016, THIRD (B)(6) 2016, FOURTH (B)(6) 2016. THE REVISION SURGERY OCCURED BECAUSE OF A REPORTED INFECTION. DURING THE SURGERY, A WASH OUT PROCEDURE WAS PERFORMED. NO COMPONENTS WERE REMOVED.

  Patient problems: Unspecified Infection

  MAUDE report 7920106 ↗
• InjuryAug 27, 2018Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X 12 MM CONGRUENT TIBIAL INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 X 14 MM ULTRA TIBIAL INSERT AND ANOTHER TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: Unspecified Infection

  MAUDE report 7817856 ↗
• InjuryJan 31, 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE THE PATIENT FELL. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X 12MM CONGRUENT TIBIAL CR INSERT WAS REMOVED AND REPLACED WITH A NEW COMPONENT OF THE SAME SIZE.

  Patient problems: Fall

  MAUDE report 7231728 ↗
• 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) 2009. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THIS REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REVISED FOR A LARGER SIZE.

  Patient problems: Pain

  MAUDE report 7053879 ↗
• InjuryFeb 6, 2017Loose or Intermittent Connection

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY IN THE KNEE. DURING THE REVISION, THE ORIGINAL SIZE 3 X 12MM INSERT AND RETAINING BOLT WERE REVISED TO A SIZE 3 X 18MM INSERT AND RETAINING BOLT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6304240 ↗