APEX PS Knee KP-20310Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00841690113140), received between Jun 22, 2018 and Sep 9, 2022 — classified as 9 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

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

  Patient problems: Unspecified Infection

  MAUDE report 15392461 ↗
• InjuryJul 6, 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 IS DATED (B)(6) 2015. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Insufficient Information

  MAUDE report 14938554 ↗
• InjuryMar 27, 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) 2021. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11579891 ↗
• InjuryJan 11, 2021Appropriate Device Problem Term/Code Not Available

  A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Unspecified Infection

  MAUDE report 11152761 ↗
• InjuryDec 4, 2020Adverse Event Without Identified Device or Use Problem

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2020. THE ORIGINAL SURGERY DATE (B)(6) 2020. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED HEMATOMA. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

  Patient problems: Hematoma

  MAUDE report 10947036 ↗
• InjuryJun 18, 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) 2019. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION ALL COMPONENTS WERE REPLACED.

  Patient problems: Unspecified Infection

  MAUDE report 10171261 ↗
• InjuryJun 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT ORIGINAL SURGERY ON (B)(6) 2020. PATIENT PRESENTED WITH A LOT OF REDNESS SURROUNDING THE KNEE AND PAIN. AFTER EXPLORATION A DEEP INFECTION WAS PRESENT. PROCEEDING WITH A WASHOUT AND POLY EXCHANGE. ORIGINAL SURGERY WAS (B)(6) 2019.

  Patient problems: Erythema; Pain; Unspecified Infection

  MAUDE report 10116654 ↗
• InjuryAug 5, 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 REVISION SURGERY OCCURED BECAUSE OF REPORTED INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.

  Patient problems: Unspecified Infection

  MAUDE report 8861941 ↗
• InjuryJun 22, 2018Naturally Worn

  THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED WEAR. DURING THE REVISION, THE ORIGINAL OMNI SIZE 3 X10MM PS INSERT AND TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 X14MM PS INSERT AND RETAINING BOLT.

  Patient problems: Failure of Implant

  MAUDE report 7630862 ↗