OMNI Knee KC-2203RRecalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 00841690101055), received between May 31, 2017 and May 21, 2025 — classified as 16 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 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) 2025. THE ORIGINAL SURGERY IS DATED (B)(6) 2023. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE TIBIAL BASEPLATE, PATELLA BUTTON, TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH A NEW IMPLANT.

  Patient problems: Aseptic loosening

  MAUDE report 22059440 ↗
• InjuryMar 28, 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)2025. THE ORIGINAL SURGERY IS DATED (B)(6)2019. THE REASON FOR REVISION IS REPORTED LOOSENING DURING THE REVISION THE TIBIAL BASEPLATE, FEMUR, TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH A NEW IMPLANTS.

  Patient problems: Aseptic loosening

  MAUDE report 21717800 ↗
• InjuryDec 4, 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 IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A REVISION IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 18263747 ↗
• InjuryNov 10, 2023Loosening 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)2023. THE ORIGINAL SURGERY IS DATED (B)(6) 2022. THE REASON FOR REVISION IS REPORTED INSTABILITY AND LOOSENING. DURING THE REVISION THE TIBIAL INSERT, PATELLA AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 18108375 ↗
• InjuryMay 10, 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 REPORTED PATIENT PAIN TO TIBIAL CYSTS. DURING THE REVISION, SURGEON REMOVED ORIGINAL TIBIAL INSERT, TIBIAL BASEPLATE AND RETAINING BOLT AND REPLACED THEM WITH NEW COMPONENTS.

  Patient problems: Cyst(s); Pain

  MAUDE report 11803719 ↗
• InjuryFeb 19, 2021Device Dislodged or Dislocated; 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) 2020. THE REASON FOR REVISION IS REPORTED SUBSIDED TIBIA. DURING THE REVISION, THE ORIGINAL FEMUR, INSERT, BASE PLATE, AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 11347087 ↗
• InjuryAug 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS UNKNOWN. THE REVISION SURGERY OCCURRED BECAUSE OF TIBIAL LOOSENING. DURING THE REVISION, THE TIBIA INSERT, TIBIAL BASEPLATE, FEMUR AND RETAINING BOLT WERE REMOVED AND REVISED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10467538 ↗
• InjuryMar 18, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2016. 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 9850173 ↗
• InjuryJan 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) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 9578231 ↗
• 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) 2019. THE REASON FOR REVISION IS POOR RANGE OF MOTION. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Loss of Range of Motion

  MAUDE report 9403792 ↗
• InjuryMay 8, 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) 2015. THE REASON FOR REVISION IS REPORTED IMPLANT LOOSENING AFTER A VEHICLE ACCIDENT. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, RETAINING BOLT, TIBIAL BASEPLATE, AND PATELLA WERE REMOVED AND REPLACED. IN ADDITION, A TIBIAL STEM WAS IMPLANTED DURING THE REVISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8591320 ↗
• InjuryAug 27, 2018Loose or Intermittent Connection

  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 REPORTED ASEPTIC LOOSENING. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 TIBIAL BASEPLATE, SIZE 3 X 11MM ULTRA INSERT, AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 REVISION TIBIAL BASEPLATE, 12MM X 100MM REVISION FLUTED STEM, SIZE 3 X 20 ULTRA INSERT, ANOTHER TIBIAL BASEPLATE RETAINING BOLT, A SIZE 3 AND SIZE 2 MODULAR TIBIA AUGMENT, A SIZE 1 X 4MM REVISION TIBIA AUGMENT, AND A 12MM AUGMENT BOLT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7817876 ↗
• InjuryJun 6, 2018Loose or Intermittent Connection

  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 LOOSENESS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 TIBIAL TRAY, TIBIAL BASEPLATE RETAINING BOLT, SIZE 3 X 11MM CS TIBIAL INSERT, AND 29 X 8MM PATELLA DOME WAS REMOVED AND REPLACED WITH A SIZE 2 REVISION TIBIAL BASEPLATE, REVISION TIBIAL BASEPLATE RETAINING BOLT, 17 X 100 X 4MM MODULAR OFFSET STEM, SIZE 3 X 16MM CS TIBIAL INSERT, AND A 29 X 8MM PATELLA DOME.

  Patient problems: No Code Available

  MAUDE report 7575329 ↗
• InjuryOct 12, 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) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF LOOSENING OF NON-OMNI CEMENT. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS. IN ADDITION, A MODULAR STEM, THREE TIBIAL AUGMENTS AND TWO TIBIAL AUGMENT BOLTS WERE IMPLANTED.

  Patient problems: Failure of Implant; No Code Available

  MAUDE report 6945597 ↗
• InjurySep 28, 2017Device Slipped

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY OCCURRED ON (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF TIBIAL LOOSENING. DURING THIS REVISION, THE ORIGINAL TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, A MODULAR TIBIAL STEM, THREE TIBIAL AUGMENTS AND TWO AUGMENT BOLTS WERE IMPLANTED.

  Patient problems: No Information

  MAUDE report 6901181 ↗
• InjuryMay 31, 2017Device Slipped

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION SURGERY OCCURRED BECAUSE OF LOOSENING. DURING THE REVISION, THE ORIGINAL SIZE 3 TIBIAL BASEPLATE, SIZE 3 X 12MM TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 MODULAR TIBIAL BASEPLATE, A SIZE 3 X 10MM TIBIAL INSERT AND A NEW RETAINING BOLT. IN ADDITION, A MODULAR STEM, 5 TIBIAL AUGMENTS AND 2 TIBIAL AUGMENT BOLTS WERE IMPLANTED.

  Patient problems: No Information

  MAUDE report 6602264 ↗