APEX PS Knee KP-20614Recalls & reported problems
Omni Life Science, Inc. · PS Insert, Size 6 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
- 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 00841690113386), received between Oct 2, 2017 and Aug 27, 2020 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Adverse Event Without Identified Device or Use Problem1
- Appropriate Device Problem Term/Code Not Available1
- Insufficient Device Problem Information1
Patient problems
- Unspecified Infection2
- Fall1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryAug 27, 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 DATED (B)(6) 2020. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Fall
MAUDE report 10462366 ↗InjuryJan 31, 2018Adverse Event Without Identified Device or Use Problem
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A SECOND KNEE REVISION SURGERY ON (B)(6) 2017. THE FIRST REVISION SURGERY OCCURRED ON (B)(6) 2017. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REVISION SURGERY OCCURRED BECAUSE OF INFECTION. DURING THE REVISION, ALL OMNI IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 7231738 ↗InjuryOct 2, 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 OMNI TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 6908462 ↗
Other PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER devices
- ATTUNE 1512-14-050Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER106 reports
- ATTUNE 1504-40-205Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall53 reports
- ATTUNE 1504-40-105Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall46 reports
- ATTUNE 1547-06-001Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall37 reports
- ATTUNE 1513-12-060Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER72 reports
- Triathlon 5521-B-300Howmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- Triathlon 5531-G-709-EHowmedica Osteonics Corp. · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall19 reports
- ATTUNE 1512-16-080Depuy (Ireland) · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 recall16 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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