APEX CR Knee KC-1104LRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690100867), received between Mar 1, 2017 and Feb 25, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2022Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. THE REASON FOR REVISION IS REPORTED TO REMOVE SPACER THAT WAS IMPLANTED DURING FIRST STAGE REVISION. DURING THE REVISION, THE ORIGINAL FEMUR AND TIBIAL INSERT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Failure of Implant

  MAUDE report 13602481 ↗
• InjuryOct 27, 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 DATE IS (B)(6) 2015. THE REASON FOR REVISION IS REPORTED FEMORAL LOOSENING. DURING THE REVISION THE ORIGINAL COMPONENTS WERE REMOVED AND REPLACED

  Patient problems: Insufficient Information

  MAUDE report 10744906 ↗
• InjuryJun 5, 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 REVISION SURGERY OCCURED BECAUSE OF REPORTED KNEE INSTABILITY. DURING THE REVISION, THE ORIGINAL FEMORAL COMPONENT, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED. IN ADDITION, A FEMORAL STEM WAS IMPLANTED AT THE TIME OF REVISION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8672090 ↗
• InjuryMar 1, 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) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 4 X 10MM INSERT, SIZE 4 FEMORAL COMPONENT AND 32MM PATELLA WERE REVISED. THE INSERT WAS REVISED TO A SIZE 2 X 14MM INSERT, THE FEMORAL COMPONENT WAS REVISED TO A 2+ LEFT, AND THE 32MM PATELLA WAS REVISED TO A 29MM PATELLA. IN ADDITION, TWO MODULAR STEMS, TWO FEMORAL DISTAL AUGMENTS AND AUGMENT BOLTS, A MODULAR BASEPLATE, A TIBIAL AUGMENT AND AUGMENT BOLT, AND A TIBIAL PEG WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 6368892 ↗