OMNI Knee KC-2203LRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841690101048), received between Jun 28, 2017 and Nov 5, 2024 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 5, 2024Patient Device Interaction Problem; Patient Device Interaction Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS ON (B)(6) 2024. THE REASON FOR REVISION IS REPORTED SUBSIDENCE OF THE TIBIAL IMPLANT. DURING THE REVISION, THE ORIGINAL BASE PLATE, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 20608864 ↗
• InjuryJul 26, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE TIBIAL TRAY, INSERT AND BOLT WERE REMOVED AND SPACER WAS PUT IN AS A HOLDER FOR A STAGE 2 SURGERY.

  Patient problems: Joint Laxity

  MAUDE report 19844259 ↗
• InjurySep 29, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2020. THE FIRST REVISION SURGERY OCCURRED ON (B)(6) 2020 AND THE ORIGINAL SURGERY DATE IS (B)(6) 2016. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL BASEPLATE AND PATELLA WERE REMOVED AND REPLACED ALONG WITH THE FEMORAL COMPONENT, TIBIAL INSERT AND RETAINING BOLT FROM THE FIRST REVISION. DURING THIS SURGERY, TWO OFFSET STEMS, A STEM BOLT, TWO POSTERIOR FEMORAL AUGMENTS, TWO DISTAL AUGMENTS, THEIR RESPECTIVE BOLTS, SIX TIBIAL AUGMENT AND TWO BOLTS WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 10603858 ↗
• InjuryFeb 26, 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) 2017. THE REASON FOR REVISION IS REPORTED THAT THE MEDIAL SIDE OF TIBIA SUBSIDED. DURING THE REVISION, THE ORIGINAL FEMUR, INSERT, BASE PLATE, PATELLA & BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 9757599 ↗
• InjuryJan 13, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION, THE TIBIAL INSERT, RETAINING BOLT AND TIBIAL BASEPLATE WERE REVISED AND REPLACED WITH NEW COMPONENTS,

  Patient problems: Fall

  MAUDE report 9582526 ↗
• InjuryNov 11, 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 (B)(6) 2015. 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, DURING THE REVISION SURGERY, FOUR TIBIAL AUGMENTS WERE ADDED WITH AUGMENT BOLTS AND A FLUTED STEM.

  Patient problems: No Code Available

  MAUDE report 9306867 ↗
• InjuryJun 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2015 AND THE FIRST REVISION IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED LIMITED RANGE OF MOTION. DURING THIS REVISION, THE TIBIAL INSERT, MODULAR STEM AND RETAINING BOLT FROM THE FIRST REVISION WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THE TIBIAL BASEPLATE FROM THE ORIGINAL SURGERY WAS REMOVED AND REPLACED ALSO. IN ADDITION, TWO TIBIAL PEGS WERE ALSO ADDED.

  Patient problems: Loss of Range of Motion; Patient Problem/Medical Problem

  MAUDE report 8696278 ↗
• InjuryAug 1, 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF TIBIAL BONE FRACTURE. DURING THE REVISION, THE SIZE 3 STANDARD TIBIAL BASEPLATE WAS REVISED TO A SIZE 3 MODULAR TIBIAL BASEPLATE, THE SIZE 3 X 12 MM TIBIAL INSERT AND RETAINING BOLT WAS REVISED TO A SIZE 3 X 16 MM INSERT AND RETAINING BOLT. IN ADDITION, DURING THE REVISION, A MODULAR STEM WAS ADDED TO THE MODULAR TIBIAL BASEPLATE ALONG WITH A MODULAR TIBIA AUGMENT AND AUGMENT BOLT.

  Patient problems: Bone Fracture(s)

  MAUDE report 6757745 ↗
• InjuryJun 28, 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) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF INSTABILITY. DURING THE REVISION, THE ORIGINAL STANDARD SIZE 3 TIBIAL BASEPLATE, SIZE 2 X 16MM TIBIAL INSERT AND RETAINING BOLT WERE REPLACED WITH A SIZE 2 MODULAR TIBIAL BASEPLATE, A SIZE 2 X 18MM TIBIAL INSERT, AND RETAINING BOLT. IN ADDITION, A MODULAR STEM AND TWO TIBIAL PEGS WERE IMPLANTED AT THE TIME OF THE REVISION.

  Patient problems: No Code Available

  MAUDE report 6675319 ↗