OMNI Knee KC-2205LRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690101086), received between Jun 18, 2018 and Jul 27, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Implant subsidence” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Implant subsidence

  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 failed/collapsed medial and anterior tibia component do to patient falls. During the revision the tibial tray, insert and bolt were removed and replaced with new devices.

  Patient problems: Fall

  MAUDE report 50013350 ↗
• InjuryFeb 4, 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 (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REMOVED THE TIBIAL INSERT, PATELLA AND BOLT AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Pain

  MAUDE report 13453195 ↗
• InjuryJun 18, 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 RIGHT TIBIAL BASEPLATE, SIZE 4X16MM CS ULTRA INSERT, 29X8MM PATELLA DOME, AND THE TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A 15X125X4MM MODULAR OFFSET STEM, SIZE 4X16MM CS ULTRA INSERT, SIZE 3 MOD. TIBIAL BASEPLATE, TIBIAL BASEPLATE RETAINING BOLT, AND MODULAR TIBIA AUGMENTS AND BOLTS.

  Patient problems: Failure of Implant

  MAUDE report 7611759 ↗