APEX Knee System KC-36033Recalls & reported problems
Omni Life Science, Inc. · Ultra Tibial Insert CS, Size 3 x 13mm · Class 2 · Implant
All models of APEX Knee System (30)
Data updated Oct 16, 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 00841690128557), received between Apr 25, 2019 and Jul 29, 2022 — 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 16, 2026.
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Appropriate Device Problem Term/Code Not Available1
Patient problems
- Insufficient Information1
- Loss of Range of Motion1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 29, 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 IS DATED (B)(6) 2021. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Insufficient Information
MAUDE report 15135131 ↗InjuryMar 25, 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) 2018. THE REASON FOR REVISION IS REPORTED POOR RANGE OF MOTION/STIFF KNEE. DURING THE REVISION, THE APEX ULTRA KNEE AND RETAINING BOLT WERE REPLACED WITH NEW COMPONENTS OF THE SAME SIZE.
Patient problems: Loss of Range of Motion
MAUDE report 9879650 ↗InjuryApr 25, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS REPORTED FOR A REVISION SURGERY THAT OCCURED ON (B)(6) 2019. THE ORIGINAL SURGERY OCCURED ON (B)(6) 2019. THE REVISION OCCURED BECAUSE OF REPORTED BECAUSE OF AN INCISION AND DIBRIDMENT SURGERY. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8552253 ↗
Other PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER devices
- ATTUNE 1506-00-005Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER589 reports
- ATTUNE 1506-00-004Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER580 reports
- JOURNEY 74012812Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER502 reports
- JOURNEY 74011856Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER438 reports
- PERSONA™ 42-5099-094-00Zimmer, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER406 reports
- JOURNEY 74011857Smith & Nephew, Inc. · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER388 reports
- ATTUNE 1506-00-007Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER288 reports
- ATTUNE 1506-00-003Depuy (Ireland) · PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER271 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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