OMNI Knee KC-35052Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00841690101376), received between Jul 6, 2018 and Sep 29, 2022 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 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) 2021. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Pain

  MAUDE report 15502997 ↗
• InjuryJun 30, 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 WAS (B)(6) 2019. 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 10214518 ↗
• InjuryApr 11, 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 A REPORTED PATIENT FALL. DURING THE REVISION, THE ULTRA TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Fall

  MAUDE report 8503688 ↗
• InjuryAug 27, 2018Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 5 LEFT CR FEMORAL COMPONENT, SIZE 5 X 12MM CONGRUENT INSERT, AND 38MM X 8MM PATELLA DOME WERE REMOVED AND REPLACED WITH ANOTHER FEMORAL COMPONENT OF THE SAME SIZE, A SIZE 5 X 10MM CONGRUENT INSERT, AND A 35MM X 8MM PATELLA DOME.

  Patient problems: Unspecified Infection

  MAUDE report 7817829 ↗
• InjuryJul 6, 2018Contamination

  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 A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 5 RIGHT CR FEMORAL COMPONENT, SIZE 5 RIGHT TIBIAL TRAY, 35MMX8MM PATELLA DOME, SIZE 5 X 12MM CONGRUENT INSERT, AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 7667448 ↗