APEX CR Knee KC-1105RRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690100898), received between Jun 16, 2017 and May 24, 2021 — classified as 4 injuries.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 24, 2021Loose 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) 2015. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE ORIGINAL TIBIAL INSERT, RETAINING BOLT AND FEMORAL COMPONENT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 11869040 ↗
• InjuryDec 17, 2018Adverse Event Without Identified Device or Use Problem

  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 REPORTED POOR RANGE OF MOTION. DURING THE REVISION, ALL ORIGINAL OMNI IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Loss of Range of Motion; No Code Available

  MAUDE report 8171591 ↗
• InjuryJun 6, 2018Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE AN INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 5 CR FEMORAL COMPONENT AND SIZE 5 CONGRUENT INSERT FROM THE 3RD REVISION WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 7575326 ↗
• InjuryJun 16, 2017Patient-Device Incompatibility

  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 A NICKEL ALLERGY. DURING THE REVISION, ALL ORIGINAL COMPONENTS WERE REMOVED. THE FEMORAL COMPONENT, TIBIAL BASEPLATE, TIBIAL INSERT, RETAINING BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NEW NON-OMNI COMPONENTS.

  Patient problems: Autoimmune Reaction

  MAUDE report 6648576 ↗