APEX CR Knee KC-1450RRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690104322), received between Nov 26, 2018 and Jul 22, 2021 — classified as 3 injuries.

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

• InjuryJul 22, 2021Appropriate 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 (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, SURGEON REMOVED THE FEMUR, TIBIAL INSERT AND BOLT AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Pain

  MAUDE report 12210910 ↗
• InjuryMay 7, 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 A REPORTED PATIENT FALL POSTOP. DURING THE REVISION THE FEMORAL COMPONENT, TIBIAL INSERT, AND RETAINING BOLT WERE REVISED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 8586145 ↗
• InjuryNov 26, 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL OMNI FEMORAL COMPONENT, TIBIAL INSERT, RETAINING BOLT AND TIBIAL BASEPLATE WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 8103249 ↗