OMNI Knee KC-36036Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690101635), received between Mar 1, 2017 and Dec 3, 2020 — classified as 4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 3, 2020Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT WAS REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 10939574 ↗
• InjurySep 27, 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 TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 9131738 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information

  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 INFECTION. DURING THE REVISION, THE ORIGINAL OMNI FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, AND RETAINING BOLT. IN ADDITION, TWO MODULAR STEMS WERE IMPLANTED, FOUR FEMORAL AUGMENTS AND AUGMENT BOLTS, AND TWO TIBIAL AUGMENTS WITH AUGMENT BOLTS WERE ADDED.

  Patient problems: Unspecified Infection

  MAUDE report 7148246 ↗
• InjuryMar 1, 2017Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2013. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 3 X 16MM INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 6368887 ↗