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APEX PS Knee KP-22211Recalls & reported problems

Omni Life Science, Inc. · PS-C Insert, Size 2 x 11mm · Class 2 · Implant

All models of APEX PS Knee (63)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
4
Deaths reported
0
Injuries reported
4
Recalls naming it
0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00841690113508), received between May 29, 2019 and May 25, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 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

Device problems

  • Appropriate Device Problem Term/Code Not Available2
  • Insufficient Device Problem Information2

Patient problems

  • Bone Fracture(s)1
  • Insufficient Information1
  • No Known Impact Or Consequence To Patient1
  • Unspecified Infection1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 25, 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) 2020. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.

    Patient problems: Insufficient Information

    MAUDE report 14501133 ↗
  • InjuryApr 17, 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) 2020. 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 11683168 ↗
  • InjuryDec 20, 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 DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED FRACTURED PATELLA. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS OF A LARGER SIZE.

    Patient problems: Bone Fracture(s)

    MAUDE report 9507176 ↗
  • InjuryMay 29, 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) 2017. THE REASON FOR REVISION IS REPORTED LAXITY. 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 8651743 ↗

Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices →

Sources and updates

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