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APEX PS Knee KP-0050LRecalls & reported problems

Omni Life Science, Inc. · PS femur, cemented Size 5 Left · Class 2 · Implant

All models of APEX PS Knee (63)

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

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00841690112143), received between Apr 12, 2017 and Jun 28, 2017 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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

Device problems

  • Appropriate Device Problem Term/Code Not Available2
  • Unstable1

Patient problems

  • Arthralgia1
  • No Code Available1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • InjuryJun 28, 2017Unstable

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2017. THE FIRST REVISION SURGERY WAS ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF LIGAMENT LAXITY AND INSTABILITY. DURING THE REVISION, THE SIZE 5 FEMORAL COMPONENT, SIZE 5 MODULAR TIBIA BASEPLATE, MODULAR TIBIAL KEEL, SIZE 5 X 14 MM TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Patient problems: No Code Available

    MAUDE report 6675331 ↗
  • InjuryMay 26, 2017Appropriate Device Problem Term/Code Not Available

    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 INFECTION. DURING THE REVISION, THE ORIGINAL SIZE 5 X 10MM TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.

    Patient problems: Unspecified Infection

    MAUDE report 6595251 ↗
  • InjuryApr 12, 2017Appropriate Device Problem Term/Code Not Available

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REVISION SURGERY OCCURRED BECAUSE OF ANTERIOR KNEE PAIN. DURING THE REVISION, THE ORIGINAL SIZE 5 FEMUR WAS REPLACED WITH A NEW SIZE 4+ FEMUR, AND THE ORIGINAL SIZE 5 X 10 MM INSERT AND RETAINING BOLT WERE REVISED AND REPLACED WITH A NEW SIZE 4 X 11 MM INSERT AND RETAINING BOLT.

    Patient problems: Arthralgia

    MAUDE report 6486066 ↗

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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