OMNI Knee KC-35060Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841690101406), received between Feb 24, 2017 and Nov 8, 2019 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 8, 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 PATIENT INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9298471 ↗
• InjuryNov 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A FOURTH KNEE REVISION SURGERY ON (B)(6) 2019. THE THIRD REVISION SURGERY OCCURED ON (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PATIENT INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9298464 ↗
• InjuryNov 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A THIRD KNEE REVISION SURGERY ON (B)(6) 2019. THE SECOND REVISION SURGERY OCCURED ON (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PATIENT INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 9298463 ↗
• InjuryOct 18, 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) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 6 X 10MM CONGRUENT INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW INSERT AND BOLT OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7978549 ↗
• InjuryJan 12, 2018Appropriate 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 KNEE TIGHTNESS. DURING THE REVISION, THE ORIGINAL OMNI INSERT WAS REMOVED AND REPLACED WITH A NEW COMPONENT.

  Patient problems: No Information

  MAUDE report 7187408 ↗
• InjurySep 7, 2017Unstable

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF 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 6850115 ↗
• InjuryMay 26, 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 6 X 10MM TIBIAL INSERT AND RETAINING BOLT WERE REVISED TO A SIZE 6 X 20MM TIBIAL INSERT AND RETAINING BOLT.

  Patient problems: Unspecified Infection

  MAUDE report 6595225 ↗
• InjuryFeb 24, 2017Inadequacy of Device Shape and/or Size

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION AND HEMATOMA. DURING THE REVISION, THE ORIGINAL SIZE 6 X 10MM INSERT AND RETAINING BOLT WERE REVISED TO SIZE 6 X 20MM INSERT AND RETAINING BOLT.

  Patient problems: Unspecified Infection

  MAUDE report 6358420 ↗