OMNI Knee KC-36040Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00841690101666), received between Feb 24, 2017 and Feb 4, 2023 — classified as 26 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (12 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 4, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2022, THE REASON FOR REVISION IS FLEXION CONTRACTURE. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Contracture

  MAUDE report 16301894 ↗
• InjuryAug 5, 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) 2021. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 15174485 ↗
• InjuryJul 28, 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 IS DATED ON (B)(6) 2016. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 15121850 ↗
• InjuryJan 4, 2022Appropriate 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 COMPROMISED INCISION SITE AND OPENING OF THE WOUND. A PREVENTATIVE WASH OUT AND POLY SWAP WAS DONE TO PREVENT POSSIBILITY OF INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 13159856 ↗
• 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) 2017. THE REASON FOR REVISION IS REPORTED PATIENT FALL AND SUBSEQUENT LOOSENING AND INFLAMED SYNOVIUM. DURING THE REVISION, TIBIAL INSERT, PATELLA BUTTON AND BOLT WERE EXCHANGED FOR A NEW IMPLANTS.

  Patient problems: Fall

  MAUDE report 13003380 ↗
• InjuryJun 8, 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, IMPLANTS WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER

  Patient problems: Unspecified Infection

  MAUDE report 11961960 ↗
• InjuryDec 16, 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 IS DATED (B)(6) 2018. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS

  Patient problems: Unspecified Infection

  MAUDE report 11017025 ↗
• InjuryNov 11, 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) 2020. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 10826852 ↗
• InjuryAug 19, 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) 2018. THE REASON FOR REVISION IS 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 10425139 ↗
• InjuryAug 11, 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) 2019. THE REASON FOR REVISION IS 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 10393294 ↗
• InjuryAug 11, 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) 2013. 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 Known Impact Or Consequence To Patient

  MAUDE report 10393172 ↗
• InjuryJun 10, 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) 2016. THE REASON FOR REVISION IS 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 10139410 ↗
• InjuryMar 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 REPORTED POOR RANGE OF MOTION/STIFF KNEE. DURING THE REVISION, THE TIBIA INSERT AND RETAINING BOLT WERE REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Loss of Range of Motion

  MAUDE report 9884689 ↗
• 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 REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED FOR NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 9582458 ↗
• InjuryAug 27, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED POSSIBLE INFECTION. DURING THE REVISION, THE ORIGINAL FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED FOR NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8936233 ↗
• InjuryMay 22, 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 INFECTION. DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND REPLACED WITH ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8633546 ↗
• InjuryApr 29, 2019Insufficient 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) 2017. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL FEMUR, TIBIAL INSERT, RETAINING BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8562140 ↗
• InjurySep 24, 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 HEMATOMA. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 7902703 ↗
• InjuryAug 27, 2018Unstable

  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 REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 10MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH SIZE 4 X 20MM ULTRA INSERT AND ANOTHER TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: No Code Available

  MAUDE report 7817855 ↗
• InjuryAug 27, 2018Unstable

  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 REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 10 MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 4 X 16 MM ULTRA INSERT AND ANOTHER TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: No Information

  MAUDE report 7817824 ↗
• 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 10MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 4 X 11MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: Unspecified Infection

  MAUDE report 7667451 ↗
• InjurySep 7, 2017Unstable

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

  Patient problems: No Code Available

  MAUDE report 6850118 ↗
• InjuryAug 29, 2017Contamination

  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 AS A SECOND STAGE REVISION FOR INFECTION. DURING THE REVISION, THE OMNI FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO A NEW FEMORAL COMPONENT, A MODULAR TIBIAL BASEPLATE, TIBIAL INSERT, RETAINING BOLT, 2 OFFSET FEMORAL STEMS, 2 TIBIAL PEGS AND A NEW PATELLA.

  Patient problems: Unspecified Infection

  MAUDE report 6827438 ↗
• InjuryApr 7, 2017Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 4+ FEMORAL COMPONENT, THE SIZE 4 TIBIAL BASEPLATE, THE SIZE 4 X 10MM INSERT AND RETAINING BOLT WERE REMOVED. THE COMPONENTS WERE REPLACED WITH A SIZE 2+ FEMORAL COMPONENT, A SIZE 4 MODULAR TIBIAL BASEPLATE, A SIZE 2 X 18MM TIBIAL INSERT AND RETAINING BOLT. IN ADDITION, A MODULAR STEM WAS IMPLANTED ALONG WITH TWO DISTAL FEMORAL AUGMENTS, TWO POSTERIOR FEMORAL AUGMENTS, FOUR AUGMENT BOLTS, AND TWO TIBIAL PEGS.

  Patient problems: Unspecified Infection

  MAUDE report 6471711 ↗
• InjuryApr 7, 2017Collapse

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF TIBIA COLLAPSE. DURING THE REVISION, THE ORIGINAL SIZE 4 STANDARD TIBIAL BASEPLATE, THE SIZE 4 X 10 MM TIBIAL INSERT AND RETAINING BOLT WERE REVISED. A NEW SIZE 4 MODULAR TIBIAL BASEPLATE, SIZE 4 X 12 MM TIBIAL INSERT AND RETAINING BOLT WERE IMPLANTED IN ADDITION TO A NODULAR OFFSET STEM, TWO TIBIAL AUGMENTS, AN AUGMENT BOLT AND AN AUGMENT PEG.

  Patient problems: Unspecified Infection

  MAUDE report 6471700 ↗