OMNI Knee KC-36042Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841690101680), received between Feb 7, 2017 and May 16, 2024 — 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.

• InjuryMay 16, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION THE INSERT AND BOLT IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Pain

  MAUDE report 19334061 ↗
• InjuryAug 26, 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 IS (B)(6) 2018. 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 15305189 ↗
• InjuryMar 8, 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)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: Insufficient Information

  MAUDE report 13695488 ↗
• InjurySep 21, 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) 2018. 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 12510920 ↗
• InjuryJul 9, 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, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 12142542 ↗
• InjuryJun 10, 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 (B)(6) 2020. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 10139413 ↗
• InjuryApr 7, 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) 2016. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, TIBIA INSERT AND FEMORAL COMPONENT WAS REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9933311 ↗
• InjuryMar 25, 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT KNEE PAIN. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REVISED AND REPLACED. IN ADDITION, A PATELLA WAS IMPLANTED DURING THE REVISION.

  Patient problems: Pain

  MAUDE report 8449858 ↗
• InjuryOct 22, 2018Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH LARGER COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 7989744 ↗
• 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 X 12MM ULTRA INSERT WAS REMOVED AND REPLACED WITH A SIZE 4 X 16MM ULTRA INSERT.

  Patient problems: Unspecified Infection

  MAUDE report 7817838 ↗
• InjuryAug 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 6758346 ↗
• InjuryFeb 7, 2017Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A THIRD KNEE REVISION SURGERY ON (B)(6) 2016. THE SECOND REVISION SURGERY IS DATED (B)(6) 2016, THE FIRST REVISION SURGERY IS DATED (B)(6) 2016 AND THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERIES OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, ALL DEVICES WERE REMOVED. THE TIBIAL INSERT, THE TIBIAL BASEPLATE, THE FEMORAL COMPONENT, RETAINING BOLT AND PATELLA WERE EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6306935 ↗