OMNI Knee KC-2204RRecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841690101079), received between May 25, 2017 and Jan 26, 2026 — classified as 10 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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.

• InjuryJan 26, 2026Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE IS (B)(6) 2025. THE REASON FOR REVISION IS REPORTED TIGHT JOINT. DURING THE REVISION, THE TIBIAL TRAY, INSERT, BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NEW IMPLANT.

  Patient problems: Joint Contracture

  MAUDE report 24176520 ↗
• InjuryFeb 7, 2025Implant subsidence; Implant subsidence

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE IS 11/04/2019. THE REASON FOR REVISION IS REPORTED INSTABILITY CAUSED BY SUBSIDENCE OF THE TIBIAL IMPLANT. DURING THE REVISION, THE ORIGINAL BASE PLATE, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 21332099 ↗
• InjuryFeb 10, 2021Material Deformation

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE SURGERY ON (B)(6) 2021. DURING THE SURGERY, THE SURGEON CHOSE TO USE A RIGHT SIDE APEX TIBIAL TRAY ON A LEFT TIBIA. THIS WAS DUE TO A DEFORMITY AND THE RIGHT SIDE TRAY HAD BETTER TIBIAL COVERAGE.

  Patient problems: Deformity/ Disfigurement

  MAUDE report 11311966 ↗
• InjuryNov 10, 2020Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REVISION SURGERY OCCURRED BECAUSE OF TIBIAL LOOSENING. DURING THE REVISION, THE TIBIA INSERT, TIBIAL BASEPLATE, FEMUR, PATELLA AND RETAINING BOLT WERE REMOVED AND REVISED.

  Patient problems: Insufficient Information

  MAUDE report 10820886 ↗
• InjurySep 29, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  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, PATELLA AND RETAINING BOLT WERE REMOVED AND REVISED.

  Patient problems: Insufficient Information

  MAUDE report 10604098 ↗
• InjuryAug 31, 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 10471459 ↗
• InjuryMay 15, 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. THEE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, FIVE TIBIAL AUGMENTS, TWO AUGMENT BOLTS AND A TIBIAL STEM WAS IMPLANTED DURING THE REVISION CASE.

  Patient problems: Fall

  MAUDE report 8612539 ↗
• InjurySep 28, 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 BONE FRACTURE. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 RIGHT TIBIAL BASEPLATE, SIZE 3 X 10MM CONGRUENT INSERT, AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 MODULAR TIBIAL BASEPLATE, SIZE 3 X 14MM CONGRUENT INSERT, ANOTHER TIBIAL BASEPLATE RETAINING BOLT, 15MM X 150MM MODULAR STEM, SIZE 3 MODULAR TIBIAL AUGMENT, 4MM REVISION TIBIAL AUGMENT BOLT, AND A 12MM MODULAR TIBIAL AUGMENT BOLT.

  Patient problems: Bone Fracture(s)

  MAUDE report 7920105 ↗
• InjuryJul 13, 2017Loose or Intermittent Connection; Inadequacy of Device Shape and/or Size

  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 PATIENT KNEE PAIN AND TIBIAL BASEPLATE LOOSENING. DURING THE REVISION, THE ORIGINAL SIZE 4 TIBIAL BASEPLATE WAS REVISED TO A SIZE 3 TIBIAL BASEPLATE, THE SIZE 4 X 10MM INSERT AND RETAINING BOLT WERE REVISED TO A SIZE 4 X 12MM INSERT AND RETAINING BOLT.

  Patient problems: Pain

  MAUDE report 6711395 ↗
• InjuryMay 25, 2017Unstable

  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 INSTABILITY. DURING THE REVISION, THE ORIGINAL SIZE 3 X 12MM TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO A SIZE 3 X 14MM TIBIAL INSERT AND RETAINING BOLT, THE SIZE 3 TIBIAL BASEPLATE WAS REVISED TO A SIZE 3 MODULAR BASEPLATE, AND THE ORIGINAL 29MM X 8MM PATELLA WAS REVISED TO A 32MM X 10MM PATELLA. IN ADDITION TO THE REVISIONS, A MODULAR OFFSET STEM, TWO TIBIAL AUGMENTS, 1 AUGMENT BOLT AND 1 AUGMENT PEG WERE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6590582 ↗