APEX Revision KneeRecalls & reported problems across all models
Omni Life Science, Inc. · 22 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 32
- Deaths reported
- 0
- Injuries reported
- 31
- Recalls
- 0
We found 22 models of APEX Revision Knee by Omni Life Science, Inc. in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2017 and Dec 15, 2025 — classified as 31 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (16 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported APEX Revision Knee problems
Device problems
- Insufficient Device Problem Information16
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem4
- Unstable2
- Contamination1
- Expiration Date Error1
- Loose or Intermittent Connection1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection22
- No Known Impact Or Consequence To Patient3
- Pain2
- Autoimmune Reaction1
- Fall1
- Joint Laxity1
- Metal Related Pathology1
- No Code Available1
APEX Revision Knee models
22 models, most reported first. Each model has its own page with its reports, recalls and device details.
- APEX Revision Knee KP-24216PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER4 reports
- APEX Revision Knee KP-24324PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX Revision Knee KP-24424PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- APEX Revision Knee KP-24116PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Revision Knee KP-24118PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Revision Knee KP-24310PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Revision Knee KP-0425LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-0425RPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-0435LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-0445RPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24212PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24214PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24218PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24314PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24316PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24318PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24412PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24414PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24416PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24516PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-24518PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Revision Knee KP-0455LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
Recent APEX Revision Knee adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryDec 15, 2025Unstable; Unstable
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Joint Laxity
MAUDE report 23801865 ↗InjurySep 9, 2024Patient-Device Incompatibility; Patient-Device Incompatibility
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY IS DATED (B)(6) 2020. THE REVISION SURGERY OCCURRED BECAUSE OF METAL ALLERGY. DURING THE REVISION ALL IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI DEVICES.
Patient problems: Metal Related Pathology
MAUDE report 20168341 ↗InjuryJan 15, 2023Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2023. THE REASON FOR REVISION IS A BILATERAL INFECTION. THE ORIGINAL SURGERY DATE FOR THE RIGHT KNEE IS (B)(6) 2022. DURING THE REVISION THE INSERT AND BOLT WAS REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 16172306 ↗InjuryNov 22, 2022Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED (B)(6) 2022. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 15847256 ↗InjuryOct 28, 2021Appropriate Device Problem Term/Code Not Available
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2019. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, FEMUR, STEM AND AUGMENTS WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 12715188 ↗InjurySep 9, 2021Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2021. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION, TIBIAL INSERT AND RETAINING BOLT, WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 12451061 ↗InjuryDec 16, 2020Appropriate Device Problem Term/Code Not Available
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2020. THE ORIGINAL SURGERY IS DATED (B)(6) 2015. THE REASON FOR REVISION IS SUSPECTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS
Patient problems: Unspecified Infection
MAUDE report 11017219 ↗InjuryDec 15, 2020Appropriate Device Problem Term/Code Not Available
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY, DATE UNKNOWN. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH AN ANTIBIOTIC SPACER.
Patient problems: Unspecified Infection
MAUDE report 11009392 ↗InjuryNov 11, 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 SUSPECTED INFECTION. DURING THE REVISION, THE ORIGINAL COMPONENTS WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 10826851 ↗InjuryOct 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) 2020. THE REASON FOR REVISION IS POSSIBLE INFECTION. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW DEVICES.
Patient problems: Unspecified Infection
MAUDE report 10673018 ↗InjuryJun 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 DATE WAS (B)(6) 2014. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH LARGER COMPONENTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10118804 ↗InjuryApr 15, 2020Loose or Intermittent Connection
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6)2020. THE ORIGINAL SURGERY IS UNKNOWN. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION, THE ORIGINAL TIBIAL INSERT AND FEMORAL COMPONENT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: No Code Available
MAUDE report 9964223 ↗InjuryApr 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 DATE IS (B)(6) 2020. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION, THE TIBIAL INSERT WAS REPLACED WITH NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 9953675 ↗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) 2016. THE REASON FOR REVISION IS REPORTED PATIENT FALL. DURING THE REVISION THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Fall
MAUDE report 9708182 ↗InjuryDec 12, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2019. THE ORIGINAL SURGERY IS DATED (B)(6) 2018. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE ORIGINAL TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Unspecified Infection
MAUDE report 9459436 ↗
Other Omni Life Science, Inc. products
All Omni Life Science, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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