OMNI Knee KC-2202RRecalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 00841690101031), received between Sep 14, 2018 and Jan 4, 2022 — 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 18, 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.

• InjuryJan 4, 2022Loose or Intermittent Connection; Appropriate 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 IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE ORIGINAL TIBIAL INSERT, TIBIAL TRAY, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 13157855 ↗
• InjuryFeb 17, 2021Collapse; Appropriate 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 UNKNOWN. THE REASON FOR REVISION IS REPORTED TIBIAL COLLAPSE. DURING THE REVISION, THE ORIGINAL FEMUR, INSERT, BASE PLATE, PATELLA & BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 11341282 ↗
• InjurySep 29, 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 DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE, INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, 4 TIBIAL AUGMENTS, AUGMENT BOLTS AND A TIBIAL STEM WAS IMPLANTED DURING THE REVISION.

  Patient problems: Joint Laxity

  MAUDE report 10603904 ↗
• InjuryJul 14, 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) 2019. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION SURGERY, THE ORIGINAL TIBIAL BASEPLATE, INSERT AND RETAINING BOLT WERE REMOVED AND REVISED TO NEW COMPONENTS. DURING THE REVISION, AN OFFSET STEM AND FOUR TIBIAL AUGMENTS AND BOLTS WERE ALSO IMPLANTED.

  Patient problems: Fall

  MAUDE report 10270824 ↗
• InjuryDec 12, 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) 2009. THE REASON FOR REVISION IS REPORTED TIBIAL SUBSIDENCE. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, A MODULAR STEM WAS IMPLANTED.

  Patient problems: No Code Available

  MAUDE report 9459431 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2011. THE REASON FOR REVISION IN REPORTED SUBSIDENCE. DURING THE REVISION ALL COMPONENTS WERE REMOVED.

  Patient problems: No Code Available

  MAUDE report 9262578 ↗
• InjuryOct 31, 2019Adverse Event Without Identified Device or Use Problem

  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 TIBIAL SUBSIDENCE. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

  Patient problems: No Code Available

  MAUDE report 9262577 ↗
• InjuryMar 4, 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED TIBIAL LOOSENING. DURING THE REVISION, THE ORIGINAL SIZE 2 TIBIAL INSERT, TIBIAL BASEPLATE AND RETAINING BOLT WERE REMOVED AND REVISED. IN ADDITION, FOUR TIBIAL AUGMENTS, AUGMENT BOLTS AND A TIBIAL STEM WERE IMPLANTED.

  Patient problems: No Information

  MAUDE report 8387695 ↗
• InjuryFeb 27, 2019Loosening of Implant Not Related to Bone-Ingrowth

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF THE PATIENT BEING INVOLVED IN A CAR ACCIDENT AND REPORTED LOOSENING OF THE TIBIA OCCURED. DURING THE REVISION, THE TIBIAL BASEPLATE, INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Patient Problem/Medical Problem

  MAUDE report 8375350 ↗
• InjuryFeb 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED LOOSENING. DURING THE REVISION, THE TIBIAL BASEPLATE, INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, A MODULAR STEM WAS IMPLANTED AT THE TIME OF REVISION SURGERY.

  Patient problems: No Code Available

  MAUDE report 8325647 ↗
• 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) 2014. THE REVISION SURGERY OCCURRED BECAUSE THE TIBIAL TRAY SUBSIDED REPORTEDLY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2 RIGHT TIBIAL BASEPLATE, SIZE 2 X 14MM ULTRA INSERT, AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH SIZE 2 REVISION TIBIAL BASEPLATE, SIZE 2 X 16MM ULTRA INSERT, ANOTHER TIBIAL BASEPLATE RETAINING BOLT, SIZE 13MM X 100MM REVISION STEM, 2 SIZE 3 X 4MM REVISION TIBIA AUGMENT, AND A 8MM REVISION TIBIA AUGMENT BOLT.

  Patient problems: No Code Available

  MAUDE report 7978546 ↗
• InjurySep 14, 2018Device Slipped

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED TIBIAL LOOSENING. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. IN ADDITION, TWO TIBIAL AUGMENTS AND A MODULAR STEM WERE IMPLANTED

  Patient problems: No Code Available

  MAUDE report 7878717 ↗