OMNI Knee KC-36060Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00841690101802), received between Mar 31, 2017 and Mar 8, 2022 — classified as 10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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)2013. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 13695968 ↗
• InjuryApr 17, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2021. THE FIRST REVISION SURGERY OCCURRED ON (B)(6) 2018 THE ORIGINAL SURGERY DATE IS (B)(6) 2017. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE ORIGINAL FEMORAL COMPONENT, TIBIAL BASEPLATE, AND PATELLA WERE REMOVED. DURING THIS REVISION, THE TIBIAL INSERT AND RETAINING BOLT FROM THE FIRST REVISION WERE ALSO REMOVED. ALL COMPONENTS WERE REPLACED WITH AN ANTIBIOTIC SPACER, A FEMORAL COMPONENT AND INSERT TO HOLD THE JOINT TOGETHER.

  Patient problems: Unspecified Infection

  MAUDE report 11683167 ↗
• InjuryAug 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) 2017. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, ALL ORIGINAL IMPLANTS WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER IN PREPARATION FOR A SECOND REVISION SURGERY IN SIX WEEKS.

  Patient problems: Unspecified Infection

  MAUDE report 8874750 ↗
• InjuryMar 29, 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 DATED (B)(6) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND LOCKING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8466170 ↗
• InjuryMar 18, 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) 2014. THE REASON FOR REVISION IS REPORTED PATIENT INFECTION. DURING THE REVISION, THE FEMORAL COMPONENT, TIBIAL INSERT, RETAINING BOLT, TIBIAL BASEPLATE AND PATELLA WERE REMOVED AND REPLACEMENT WITH A TEMPORARY ANTIBIOTIC SPACER.

  Patient problems: Unspecified Infection

  MAUDE report 8430127 ↗
• InjuryOct 19, 2018Appropriate Device Problem Term/Code Not Available

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY DATE IS (B)(6) 2012. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED AVASCULAR NECROSIS OF THE PATELLA. DURING THE REVISION, THE OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REVISED WITH NEW COMPONENTS.

  Patient problems: Necrosis

  MAUDE report 7986397 ↗
• InjuryOct 18, 2018Microbial Contamination of Device

  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 6 X 10MM ULTRA INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7978555 ↗
• InjuryJul 6, 2018Microbial Contamination of Device

  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 6X10MM TIBIAL INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7667481 ↗
• InjuryApr 27, 2017Insufficient Device Problem Information

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN. DURING THE REVISION, THE ORIGINAL SIZE 6 X 10MM INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Pain

  MAUDE report 6527505 ↗
• InjuryMar 31, 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE SUSPECTED INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 6 X 10MM INSERT AND RETAINING BOLT WERE REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 6450802 ↗