OMNI Knee KC-36024Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841690101550), received between Feb 10, 2017 and Jul 22, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 16, 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.

• InjuryJul 22, 2025Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THIS EVENT WAS REPORTED TO CORIN'S CLINICAL DEPARTMENT ON (B)(6) 2025 UNDER CASE STUDY (B)(6).

  Patient problems: Joint Laxity

  MAUDE report 22563941 ↗
• InjuryAug 9, 2022Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS PATIENT FALL. DURING THE REVISION THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 15191890 ↗
• InjuryDec 22, 2021Naturally Worn

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2009. THE REASON FOR REVISION POLY WEAR. DURING THE REVISION A POLY SWAP OCCURRED REPLACING THE TIBIAL INSERT AND RETAINING BOLT.

  Patient problems: Insufficient Information

  MAUDE report 13062058 ↗
• InjuryDec 14, 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 PATIENT FALL AND SUBSEQUENT LOOSE KNEE. DURING THE REVISION, TIBIAL INSERT, PATELLA BUTTON AND BOLT WERE REMOVED. THE TIBIAL INSERT WAS REPLACED WITH A THICKER SIZE.

  Patient problems: Fall

  MAUDE report 13003635 ↗
• InjuryDec 3, 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) 2014, THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF A LARGER SIZE.

  Patient problems: No Code Available

  MAUDE report 9403790 ↗
• InjurySep 6, 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) 2018. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED POOR RANGE OF MOTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO SMALLER SIZE.

  Patient problems: Loss of Range of Motion; Patient Problem/Medical Problem

  MAUDE report 8972435 ↗
• InjuryMay 29, 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND EXCHANGED FOR NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8651742 ↗
• InjuryOct 18, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED INFECTION. DURING THE REVISION, THE TIBIAL BASEPLATE, FEMORAL COMPONENT, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS. IN ADDITION, A FEMORAL STEM, SEVERAL FEMORAL AUGMENTS AND AUGMENT BOLTS, A TIBIAL STEM, TIBIAL AUGMENTS AND AUGMENT BOLTS, AND A PATELLA WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 7980113 ↗
• InjuryFeb 10, 2017Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY IN THE KNEE. DURING THE REVISION, THE ORIGINAL SIZE 2 X 14 MM TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO A SIZE 2 X 18 MM INSERT AND RETAINING BOLT.

  Patient problems: No Information

  MAUDE report 6323488 ↗