APEX PS Knee KP-20510Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00841690113287), received between Mar 31, 2017 and May 5, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryMay 5, 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) 2018. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE BILATERAL REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED FROM BOTH KNEES AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11781494 ↗
• 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 10196749 ↗
• InjuryJun 11, 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) 2020. 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 10145408 ↗
• InjuryMay 12, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, POLY INSERT AND BOLT WERE REMOVED AND REPLACED WITH LARGER SIZE.

  Patient problems: No Code Available

  MAUDE report 10047551 ↗
• InjuryMay 6, 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 DATED (B)(6) 2018. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED PATIENT FALL. DURING THE REVISION, THE TIBIAL INSERT, FEMUR AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Fall

  MAUDE report 10029609 ↗
• InjuryDec 22, 2017Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2017. THE FIRST REVISION SURGERY IS DATED (B)(6) 2017 AND THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THIS REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THIS REVISION, THE ORIGINAL OMNI IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 7142734 ↗
• InjuryMar 31, 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) 2014. THE REVISION SURGERY OCCURRED BECAUSE SUSPECTED INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 5 X 10MM INSERT AND RETAINING BOLT WERE REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 6451296 ↗