OMNI Knee KC-36031Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00841690101604), received between Jun 1, 2017 and Jul 10, 2025 — classified as 15 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJul 10, 2025Loosening 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) 2025. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 22468088 ↗
• InjuryJul 10, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2024. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 19709384 ↗
• InjuryMay 16, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE (B)(6) 2021. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION THE INSERT AND BOLT IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS. THE PATELLA WAS RESURFACED DURING THE REVISION.

  Patient problems: Pain

  MAUDE report 19333771 ↗
• InjuryJul 15, 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 IS (B)(6) 2022. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 15034880 ↗
• InjuryMar 21, 2022Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY (B)(6) 2022. THE ORIGINAL SURGERY DATE (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REMOVED THE TIBIAL INSERT AND BOLT AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Pain

  MAUDE report 13843028 ↗
• InjuryMar 18, 2022Unstable

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2017. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13803768 ↗
• InjuryDec 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) 2019. THE REASON FOR REVISION IS REPORTED PAIN AND INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 9445106 ↗
• InjuryJan 14, 2019Adverse 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT LIGAMENT FAILURE. DURING THE REVISION, THE ORIGINAL OMNI FEMORAL COMPONENT, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED FROM CRUCIATE RETAINING COMPONENTS TO POSTERIOR STABILIZING COMPONENTS.

  Patient problems: Damage to Ligament(s)

  MAUDE report 8246259 ↗
• InjuryDec 11, 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 PAIN. DURING THE REVISION, THE ORIGINAL OMNI INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 8150172 ↗
• InjuryOct 19, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDSERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY DATE IS (B)(6) 2016. THE REVISION SURGERY OCCURED BECAUSE OF A REPORTED PATIENT FALL. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, RETAINING BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 7986398 ↗
• InjuryOct 3, 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 AN ALLEGED PATIENT FALL. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X 11MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 X 12MM ULTRA INSERT AND ANOTHER TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: Fall

  MAUDE report 7931766 ↗
• InjuryAug 27, 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) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED OSTEOLYSIS. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X 11MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 2 X 14MM ULTRA INSERT AND ANOTHER TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: Osteolysis

  MAUDE report 7817835 ↗
• InjuryAug 27, 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) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X 11MM ULTRA CONGRUENT TIBIAL INSERT WAS REMOVED AND REPLACED WITH ANOTHER TIBIAL INSERT OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7817796 ↗
• InjuryJun 28, 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF AN INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 3+ LEFT FEMORAL COMPONENT, SIZE 4 TIBIAL BASEPLATE, SIZE 3 X 14MM TIBIAL INSERT, AND RETAINING BOLT WERE REVISED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 6675313 ↗
• InjuryJun 1, 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 3 X 11MM TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 6604188 ↗