OMNI Knee KC-40328Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00841690101956), received between Jul 6, 2018 and Oct 7, 2024 — classified as 14 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REASON FOR REVISION IS PAIN DUE TO PATELLA FRACTURE. DURING THE REVISION THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW PATELLA IMPLANT.

  Patient problems: Pain

  MAUDE report 20382502 ↗
• InjuryMay 16, 2024Loosening 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) 2024. THE ORIGINAL SURGERY IS DATED (B)(6) 2022. THE REASON FOR REVISION IS REPORTED LOOSENING OF THE PATELLA BUTTON. DURING THE REVISION THE IMPLANT WAS REMOVED AND REPLACED WITH A NEW PATELLA IMPLANT.

  Patient problems: Joint Laxity

  MAUDE report 19333561 ↗
• InjuryAug 17, 2022Loosening of Implant Not Related to Bone-Ingrowth

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE ORIGINAL PATELLA, WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

  Patient problems: Failure of Implant

  MAUDE report 15240538 ↗
• InjuryMay 23, 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 ON (B)(6) 2021. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REMOVED THE PATELLA AND REPLACED WITH NEW IMPLANT.

  Patient problems: Pain

  MAUDE report 14476912 ↗
• InjuryJul 20, 2021Loose or Intermittent Connection

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY IS DATED (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATIENT FALL AND SUBSEQUENT PATELLA LOOSENING. DURING THE REVISION, ALL ORIGINAL PATELLA IMPLANT WAS REMOVED AND REPLACED.

  Patient problems: Fall

  MAUDE report 12199617 ↗
• InjuryMay 27, 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) 2016. THE REASON FOR REVISION IS REPORTED PATELLAR TRACKING. DURING THE REVISION, THE ORIGINAL PATELLA COMPONENT WAS REMOVED AND REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 11899080 ↗
• InjuryJan 7, 2021Malposition of Device; Appropriate 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) 2020. THE REASON FOR REVISION IS REPORTED MALPOSITIONED PATELLA IMPLANT. DURING THE REVISION, SURGEON REPLACED THE PATELLA IMPLANT.

  Patient problems: Insufficient Information

  MAUDE report 11137059 ↗
• InjuryApr 14, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2020. THE ORIGINAL SURGERY DATE WAS (B)(6) 2015. THE REASON FOR REVISION IS REPORTED PATELLAR FRACTURE. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, PATELLA AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 9958895 ↗
• 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) 2014. THE REASON FOR REVISION IS REPORTED PATELLA LOOSENING. DURING THE REVISION, ALL DEVICES WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8759334 ↗
• InjuryJun 18, 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) 2018. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL 32MM X 8MM PATELLA WAS REMOVED AND EXCHANGED FOR A 35MM X 8MM PATELLA.

  Patient problems: Pain

  MAUDE report 8709778 ↗
• InjuryApr 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR KNEE REVISION SURGERY THAT OCCURED ON (B)(6) 2019. THE ORIGINAL SURGERY DATE IS (B)(6) 2013. THE REASON FOR REVISION IS REPORTED PATIENT PAIN AND LOOSENING. DURING THE REVISION, THE ORIGINAL PATELLA, INSERT AND LOCKING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 8547045 ↗
• InjuryMar 29, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED PATIENT TRAUMA. IT IS UNKNOWN WHAT TYPE OF PATIENT TRAUMA OCCURED . DURING THE REVISION, THE ORIGINAL PATELLA WAS REMOVED AND REPLACED WITH A NEW PATELLA COMPONENT.

  Patient problems: No Code Available; Patient Problem/Medical Problem

  MAUDE report 8466171 ↗
• InjuryNov 13, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT FALL. DURING THE REVISION, THE ORIGINAL OMNI PATELLA, INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: Fall

  MAUDE report 8064495 ↗
• InjuryJul 6, 2018Break

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED FALL. DURING THE REVISION, THE ORIGINAL OMNI 32MM X 8MM PATELLA DOME WAS REMOVED AND REPLACED WITH A 35MM X 8MM PATELLA DOME.

  Patient problems: Fall

  MAUDE report 7667443 ↗