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APEX PS Knee KP-20514Recalls & reported problems

Omni Life Science, Inc. · PS Insert, Size 5 x 14mm · Class 2 · Implant

All models of APEX PS Knee (63)

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

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00841690113317), received between Aug 27, 2018 and Aug 27, 2018 — classified as 1 injury.

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

  • Unstable1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryAug 27, 2018Unstable

    THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2018. THE ORIGINAL SURGERY IS DATED (B)(6) 2013 . THE REVISION SURGERY OCCURRED BECAUSE OF REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL OMNI SIZE 5 X 14MM PS INSERT AND 14MM PS TIBIAL BASEPLATE RETAINING BOLT WERE REMOVED AND REPLACED WITH A SIZE 5 X 16MM PS INSERT AND A 16 MM PS TIBIAL BASEPLATE RETAINING BOLT.

    Patient problems: No Information

    MAUDE report 7817819 ↗

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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