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APEX PS Knee KP-0050RRecalls & reported problems

Omni Life Science, Inc. · PS femur, cemented Size 5 Right · 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 00841690112150), received between Jan 3, 2019 and Nov 27, 2025 — classified as 3 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Insufficient Device Problem Information2
  • Fracture1

Patient problems

  • Bone Fracture(s)1
  • Implant Pain1
  • Insufficient Information1

Recent adverse event reports

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

  • InjuryNov 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

    UNBEARABLE PAIN 2 DAYS POST SURGERY FOLLOWING AN APEX TOTAL KNEE REPLACEMENT.

    Patient problems: Implant Pain

    MAUDE report 23665964 ↗
  • InjuryNov 4, 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 DATE IS (B)(6) 2016. THE REASON FOR REVISION IS REPORTED FEMORAL LOOSENING FROM PATIENT FALL. DURING THE REVISION THE ORIGINAL COMPONENTS WERE REMOVED AND REPLACED

    Patient problems: Insufficient Information

    MAUDE report 10789205 ↗
  • InjuryJan 3, 2019Fracture

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE SURGERY ON (B)(6) 2018. DURING THE SURGERY, THE INTERCONDYLAR NOTCH WAS FRACTURED UPON FINAL IMPLANTATION OF THE FEMORAL COMPONENT.

    Patient problems: Bone Fracture(s)

    MAUDE report 8212217 ↗

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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