OMNI Knee KC-36022Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841690101543), received between Dec 6, 2017 and Nov 1, 2022 — classified as 12 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2022. THE ORIGINAL SURGERY DATE (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION SURGEON REMOVED THE TIBIAL INSERT AND BOLT REPLACED WITH NEW IMPLANT.

  Patient problems: Pain

  MAUDE report 15709869 ↗
• InjuryNov 1, 2022Loosening 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) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED INSTABILITY AND LOOSENING. DURING THE REVISION THE TIBIAL INSERT, PATELLA AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW IMPLANTS.

  Patient problems: Joint Laxity

  MAUDE report 15708157 ↗
• InjuryNov 8, 2021Loose or Intermittent Connection; 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) 2018. THE REASON FOR REVISION IS REPORTED PATIENT FALL AND SUBSEQUENT LOOSE KNEE. DURING THE REVISION, TIBIAL INSERT AND BOLT WERE EXCHANGED FOR A TICKER POLY INSERT.

  Patient problems: Fall

  MAUDE report 12774003 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. 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 12441371 ↗
• InjuryJul 7, 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 INFECTION. DURING THE REVISION, EVERY COMPONENT WAS REMOVED AND REPLACED WITH REVISION COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12130700 ↗
• InjurySep 29, 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 IS (B)(6) 2013. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 10603818 ↗
• InjuryApr 29, 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 IS DATED (B)(6) 2020. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT FALL. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW LARGER COMPONENTS.

  Patient problems: Fall

  MAUDE report 10009942 ↗
• InjuryAug 5, 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) 2008. THE REASON FOR REVISION IS REPORTED JOINT LAXITY. DURING THE REVISION, THE ORIGINAL FEMORAL COMPONENT, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH LARGER COMPONENTS. IN ADDITION, TWO FEMORAL AUGMENTS WERE ADDED TO THE PATIENTS FEMUR.

  Patient problems: Failure of Implant

  MAUDE report 8861942 ↗
• InjuryMar 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED PATIENT INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8416922 ↗
• InjuryDec 11, 2018Unstable

  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 REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 8150169 ↗
• InjuryOct 19, 2018Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS A REPORTED PATIENT FALL AND SUBSEQUENT KNEE INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETIANING BOLT WERE REVISED TO A LARGER SIZE.

  Patient problems: Fall

  MAUDE report 7986392 ↗
• InjuryDec 6, 2017Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2008. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY. DURING THIS REVISION, THE ORIGINAL OMNI TIBIAL BASEPLATE AND RETAINING BOLT WERE REVISED TO THICKER COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 7087692 ↗