APEX PS Knee KP-20210Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00841690113072), received between Aug 27, 2018 and Jul 21, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2026Loosening of Implant Not Related to Bone-Ingrowth

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Aseptic loosening

  MAUDE report 25889232 ↗
• InjuryJul 20, 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) 2016. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 15067583 ↗
• InjuryMay 24, 2022Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 14492141 ↗
• InjuryOct 22, 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 UNKNOWN. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW DEVICES.

  Patient problems: Unspecified Infection

  MAUDE report 10723359 ↗
• InjuryJun 26, 2020Insufficient 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 (B)(6) 2015. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, WASHOUT AND TIBIA INSERT EXCHANGE WERE PERFORMED.

  Patient problems: Unspecified Infection

  MAUDE report 10203476 ↗
• InjuryJan 13, 2020Insufficient 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 DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED NECROTIC TISSUE AND POSSIBLE INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 9582530 ↗
• InjuryMay 14, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  A PATIENT UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2017. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8608721 ↗
• InjuryAug 27, 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) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2+ RIGHT PS FEMORAL COMPONENT, SIZE 2 X 10MM PS INSERT, 10-11M TIBIAL BASEPLATE RETAINING BOLT, SIZE 2 RIGHT TIBIAL TRAY, AND 35MM X 8MM PATELLA DOME WERE REMOVED AND REPLACED WITH A COMPETITOR'S PRODUCT.

  Patient problems: Unspecified Infection

  MAUDE report 7817818 ↗