APEX PS Knee KP-0010LRecalls & reported problems
Omni Life Science, Inc. · PS femur, cemented Size 1 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00841690112006), received between Feb 13, 2020 and Mar 21, 2025 — classified as 2 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.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information1
- Patient Device Interaction Problem1
Patient problems
- Failure of Implant1
- Implant Pain1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 21, 2025Patient Device Interaction Problem; Patient Device Interaction Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, DURING THE REVISION, THE ORIGINAL FEMUR, TIBIAL PLATE, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Implant Pain
MAUDE report 21661972 ↗InjuryFeb 13, 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) 2017. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, ALL COMPONENTS WERE REMOVED AND A HINGE WAS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 9705699 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page