OMNI Knee KC-40358Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841690101970), received between Dec 27, 2017 and Apr 5, 2023 — classified as 8 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  APEX REVISION AFTER APPROXIMATIVELY 7 YEARS DUE TO INSTABILITY (PATIENT DISLOCATED GOING UPSTAIRS).

  Patient problems: Joint Dislocation

  MAUDE report 16681880 ↗
• InjuryJun 8, 2022Fracture; Appropriate 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 IS DATED (B)(6) 2020. THE REASON FOR REVISION IS REPORTED FRACTURE FROM PATIENT FALL. DURING THE REVISION THE PATELLA BUTTON WAS REMOVED AND REPLACED WITH A NEW IMPLANT.

  Patient problems: Fall

  MAUDE report 14632477 ↗
• InjuryMar 4, 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 REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REMOVED AND REPLACED ORIGINAL PATELLA.

  Patient problems: Pain

  MAUDE report 11418605 ↗
• InjuryJun 19, 2020Insufficient 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 DATE IS (B)(6) 2018. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON WANTED TO REMOVE SCAR TISSUE BUILD UP IN THE AREA AND REPLACE THE PATELLA.

  Patient problems: Pain

  MAUDE report 10174847 ↗
• InjuryOct 11, 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 PATIENT FALL. DURING THE REVISION, THE PATIENTS PATELLAR COMPONENT, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall; Patient Problem/Medical Problem

  MAUDE report 9182631 ↗
• InjurySep 10, 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) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE TIBIAL INSERT, RETAINING BOLT, AND PATELLA WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 8983541 ↗
• InjuryJul 6, 2018Failure to Align

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON 03/14/2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED MAL-ALIGNMENT. DURING THE REVISION, THE ORIGINAL OMNI 35MM X 8MM PATELLA DOME WAS REMOVED AND REPLACED WITH A 38MM X 10MM PATELLA DOME.

  Patient problems: No Code Available

  MAUDE report 7667478 ↗
• InjuryDec 27, 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) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THE REVISION, THE ORIGINAL OMNI PATELLA WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

  Patient problems: Pain

  MAUDE report 7148247 ↗