APEX PS Knee KP-20414Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841690113249), received between Feb 22, 2017 and Apr 6, 2021 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryApr 6, 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 IS (B)(6) 2019. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11625646 ↗
• InjuryJan 11, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 11152760 ↗
• InjuryDec 31, 2020Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2017. THE REASON FOR REVISION IS REPORTED POOR RANGE OF MOTION. DURING THE REVISION, THE INSERT AND RETAINING BOLT WERE REPLACED WITH NEW COMPONENTS.

  Patient problems: Loss of Range of Motion

  MAUDE report 11100399 ↗
• InjuryJun 25, 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 (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 10195440 ↗
• InjuryFeb 6, 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 8313148 ↗
• InjuryAug 27, 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 LEFT PS FEMORAL COMPONENT, SIZE 4 X 14 MM PS INSERT, TIBIAL BASEPLATE RETAINING BOLT, SIZE 4 LEFT TIBIAL TRAY, AND 38 MM X 8 MM PATELLA DOME WERE REMOVED AND REPLACED WITH REVISION APEX KNEE IMPLANTS.

  Patient problems: Unspecified Infection

  MAUDE report 7817865 ↗
• InjuryJun 29, 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) 2017. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 4 LEFT PS FEMORAL COMPONENT, SIZE 4 LEFT TIBIAL BASEPLATE, SIZE 4 X 14MM PS INSERT, 14 MM TIBIAL BASEPLATE RETAINING BOLT, AND 35X8MM PATELLA DOME WERE REMOVED AND REPLACED WITH A COMPETITORS PRODUCTS.

  Patient problems: Unspecified Infection

  MAUDE report 7652767 ↗
• InjuryOct 2, 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 INFECTION. DURING THE REVISION, THE ORIGINAL OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 6908457 ↗
• InjuryFeb 22, 2017Microbial Contamination of Device; Device Operates Differently Than Expected

  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 14 MM INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 6350267 ↗