APEX PS Knee KP-20212Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00841690113096), received between Mar 1, 2017 and Apr 10, 2021 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2021Unstable

  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 REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 11646655 ↗
• 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 DATE IS (B)(6) 2020. 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: Joint Laxity

  MAUDE report 10744896 ↗
• 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 DATE WAS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH LARGER COMPONENTS.

  Patient problems: No Code Available

  MAUDE report 10145426 ↗
• InjuryJun 13, 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) 2014. THE REVISION SURGERY OCCURED BECAUSE OF REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, RETAINING BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 8696282 ↗
• InjuryJun 19, 2018Naturally Worn

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2012. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED WEAR. DURING THE REVISION, THE ORIGINAL OMNI SIZE 2X12MM PS INSERT AND TIBIA BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 2X18MM PS INSERT AND RETAINING BOLT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7615950 ↗
• 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) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 2 X 12 MM INSERT AND RETAINING BOLT WERE REVISED TO NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 6368896 ↗