OMNI Knee KC-36062Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841690101826), received between Jun 29, 2018 and Jan 5, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 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.

• InjuryJan 5, 2026Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 23956701 ↗
• InjuryJun 10, 2022Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 14653386 ↗
• InjuryOct 26, 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 POSSIBLE INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12700430 ↗
• InjuryApr 15, 2021Fracture; 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 IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED PATIENT FALL AND SUBSEQUENT PERIPROSTHETIC FRACTURE. DURING THE REVISION, ALL ORIGINAL COMPONENTS WERE REMOVED AND REPLACED.

  Patient problems: Fall

  MAUDE report 11675076 ↗
• InjuryMay 20, 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 REPORTED POSSIBLE INFECTION. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL BASEPLATE AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8625722 ↗
• InjuryJun 29, 2018Adverse Event Without Identified Device or Use Problem

  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 INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 6 X 12MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7652766 ↗