OMNI knee KC-2204LRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841690101062), received between Aug 31, 2017 and Apr 3, 2025 — classified as 6 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 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Implant subsidence; Implant subsidence

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2023. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. THE REASON FOR REVISION IS REPORTED SUBSIDENCE OF THE TIBIAL IMPLANT. DURING THE REVISION, THE ORIGINAL TIBIAL BASE PLATE, FEMUR, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Aseptic loosening

  MAUDE report 21761044 ↗
• InjuryFeb 20, 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 UNKNOWN. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, RETAINING BOLT AND TIBIAL BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 9734451 ↗
• 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) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, BASEPLATE AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8757598 ↗
• InjuryMar 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE REPORTEDLY THE TIBIA SUBSIDED AND FEMUR BECAME LOOSE. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE, TIBIAL INSERT, FEMORAL COMPONENT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, TWO MODULAR STEMS, A STEM BOLT, TWO FEMORAL AUGMENTS AND BOLTS, AND FOUR TIBIAL AUGMENTS AND BOLTS WERE IMPLANTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8449857 ↗
• InjuryNov 22, 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) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THIS REVISION, ALL ORIGINAL OMNI IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT

  Patient problems: Pain

  MAUDE report 7053887 ↗
• InjuryAug 31, 2017Break

  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 A BROKEN TIBIAL COMPONENT. DURING THE REVISION, THE TIBIAL BASEPLATE WAS REMOVED AND REPLACED WITH A MODULAR TIBIAL BASEPLATE, THE 4 X 10 MM INSERT WAS REVISED TO A NEW INSERT OF THE SAME SIZE, AND THE RETAINING BOLT WAS REVISED TO A NEW COMPONENT. IN ADDITION TO THE COMPONENTS REMOVED, A TIBIAL MODULAR STEM, FOUR TIBIAL AUGMENTS AND TWO TIBIAL AUGMENT BOLTS WERE IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 6836690 ↗