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APEX PS Knee KP-20311Recalls & reported problems

Omni Life Science, Inc. · PS Insert, Size 3 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 00841690113157), received between Mar 18, 2019 and Jun 4, 2021 — classified as 4 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

Device problems

  • Insufficient Device Problem Information3
  • Appropriate Device Problem Term/Code Not Available1

Patient problems

  • Insufficient Information2
  • Fall1
  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

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

  • InjuryJun 4, 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) 2013. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED.

    Patient problems: Insufficient Information

    MAUDE report 11942456 ↗
  • InjuryNov 17, 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: Insufficient Information

    MAUDE report 10857838 ↗
  • InjuryJun 24, 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) 2018. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT, RETAINING BOLT, TIBIAL BASEPLATE AND FEMUR WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 10191634 ↗
  • InjuryMar 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2014. THE REVISION SURGERY OCCURRED BECAUSE OF A REPORTED PATIENT FALL AND THE IMPLANT BECAME LOOSE. DURING THE REVISION, THE ORIGINAL SIZE 3 X 11MM TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 3 X 14MM TIBIAL INSERT AND RETAINING BOLT.

    Patient problems: Fall

    MAUDE report 8430124 ↗

Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices

All PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices →

Sources and updates

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