OMNI Knee KC-40388Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841690101994), received between Dec 17, 2018 and Dec 22, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 22, 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 DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE PETALLA, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Aseptic loosening

  MAUDE report 23862588 ↗
• InjuryAug 13, 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) 2024. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE PATELLA BUTTON WAS REMOVED AND REPLACED WITH A NEW IMPLANT.

  Patient problems: Aseptic loosening

  MAUDE report 22793611 ↗
• InjuryJun 11, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR PATIENT WAS REVISED FOR PATELLAFEMORAL PAIN ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS UNKNOWN. THE PATELLA WAS REMOVED AND REPLACED THEM WITH NEW COMPONENT.

  Patient problems: Pain

  MAUDE report 11983538 ↗
• 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) 2017. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION, THE ORIGINAL PATELLA, TIBIAL INSERT, AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8759333 ↗
• InjuryDec 17, 2018Device Dislodged or Dislocated

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

  Patient problems: No Information

  MAUDE report 8171585 ↗