APEX PS Knee KP-0030LRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690112068), received between Jun 1, 2017 and Jun 30, 2021 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 30, 2021Loose or Intermittent Connection; Appropriate 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 IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE ORIGINAL TIBIAL INSERT, TIBIAL TRAY, RETAINING BOLT, PATELLA AND FEMORAL COMPONENT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 12094319 ↗
• InjuryJun 1, 2017Inadequacy of Device Shape and/or Size

  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 PATIENT PAIN, AND FLEXION CONTRACTURE. DURING THE REVISION, THE ORIGINAL SIZE 3+ FEMORAL COMPONENT WAS REPLACED WITH A NEW SIZE 3+ FEMORAL COMPONENT, THE ORIGINAL SIZE 3 X 10MM INSERT AND RETAINING BOLT WERE REVISED TO A SIZE 3 X 11MM INSERT AND RETAINING BOLT.

  Patient problems: Pain

  MAUDE report 6604190 ↗