OMNI Knee KC-36050Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00841690101734), received between Nov 10, 2017 and May 5, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 2025Adverse 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) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2023. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED ANTIBIOTIC SPACERS.

  Patient problems: Unspecified Infection

  MAUDE report 21959746 ↗
• InjuryJan 10, 2024Adverse 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 DATE IS (B)(6) 2023. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 18489914 ↗
• InjuryOct 27, 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 DATE IS (B)(6) 2023. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 18020014 ↗
• InjuryOct 14, 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 10/08/2019. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION SURGEON REMOVED THE TIBIAL INSERT AND BOLT REPLACED WITH NEW IMPLANT.

  Patient problems: Pain

  MAUDE report 15610370 ↗
• InjurySep 13, 2022Adverse 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) 2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 15414572 ↗
• InjuryJul 6, 2022Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. 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 14939900 ↗
• InjuryJun 17, 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) 2019. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE FEMORAL COMPONENT AND TIBIAL INSERT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12019890 ↗
• InjuryMar 18, 2021Appropriate 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) 2020. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WAS REMOVED AND REPLACED WITH NEW REVISION COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11521456 ↗
• InjuryJul 17, 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 (B)(6) 2017. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THEY REMOVED THE ORIGINAL TIBIAL INSERT AND LOCKING BOLT AND REPLACED THEM WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 10290733 ↗
• InjuryJun 24, 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 REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REPLACE TIBIA INSERT AND RETAINING BOLT.

  Patient problems: Pain

  MAUDE report 10191693 ↗
• InjuryMar 12, 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 SUSPECTED INFECTION. DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND AN ANTIBIOTIC SPACER WAS PUT IN WITH PLANS TO COMPLETE REVISION AT A LATER DATE.

  Patient problems: Unspecified Infection

  MAUDE report 9825903 ↗
• InjuryJan 13, 2020Insufficient 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 SURGERY OCCURED BECAUSE OF REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9582517 ↗
• InjuryDec 13, 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 REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 9469610 ↗
• InjuryOct 28, 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 REASON FOR REVISION IS REPORTED POOR RANGE OF MOTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

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

  MAUDE report 9247750 ↗
• InjurySep 18, 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) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN AND INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF A LARGER SIZE.

  Patient problems: Pain

  MAUDE report 9085098 ↗
• InjuryJul 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) 2019. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 8757600 ↗
• 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 AND THE FIRST REVISION IS DATED (B)(6) 2018. THIS REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 5 LEFT CR FEMORAL COMPONENT AND SIZE 5X10MM TIBIAL INSERT FROM THE FIRST REVISION WERE REMOVED AND REPLACED WITH COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7667446 ↗
• InjuryFeb 7, 2018Adverse Event Without Identified Device or Use Problem

  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 INFECTION. DURING THE REVISION, THE OMNI INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 7249483 ↗
• InjuryJan 19, 2018Adverse 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 THE REVISION, THE ORIGINAL OMNI SIZE 5 X 10MM INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7207832 ↗
• InjuryNov 10, 2017Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THIS REVISION, THE ORIGINAL OMNI SIZE 5 X 10 MM TIBIAL INSERT AND RETAINING BOLT WERE EXCHANGED FOR NEW IMPLANTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7022591 ↗