APEX PS Knee KP-22310Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690113560), received between Oct 18, 2018 and Apr 10, 2024 — classified as 3 injuries.

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

• InjuryApr 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A BI LATERAL KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION THE TIBIAL INSERTS AND RETAINING BOLTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

  Patient problems: Bacterial Infection

  MAUDE report 19080764 ↗
• InjuryMay 1, 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) 2018. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Pain

  MAUDE report 8570260 ↗
• InjuryOct 18, 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) 2018. THE REVISION SURGERY OCCURRED BECAUSE REPORTEDLY, THE PATIENT HAD RUPTURED A QUADRICEP TENDON. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X 10MM PS-C INSERT AND 10MM TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 X 12MM PS-C INSERT AND A 12MM TIBIAL BASEPLATE RETAINING BOLT.

  Patient problems: Rupture

  MAUDE report 7978552 ↗