APEX Knee SystemRecalls & reported problems across all models
Omni Life Science, Inc. · 30 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls
- 0
We found 30 models of APEX Knee System by Omni Life Science, Inc. in the FDA's device registry (GUDID). Together they are named in 38 adverse event reports in the FDA's MAUDE database, received between Feb 11, 2019 and Aug 13, 2026 — classified as 38 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (6 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 Knee System problems
Device problems
- Adverse Event Without Identified Device or Use Problem15
- Appropriate Device Problem Term/Code Not Available9
- Insufficient Device Problem Information6
- Unstable3
- Loosening of Implant Not Related to Bone-Ingrowth2
- Patient Device Interaction Problem2
- Collapse1
- Loose or Intermittent Connection1
Patient problems
- Unspecified Infection19
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Aseptic loosening2
- Insufficient Information2
- Loss of Range of Motion2
- Pain2
- Bone Fracture(s)1
- Foreign Body In Patient1
APEX Knee System models
30 models, most reported first. Each model has its own page with its reports, recalls and device details.
- APEX Knee System KC-36033PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX Knee System KC-36043PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Knee System KC-1155RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Knee System EC-35042PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Knee System EC-35050PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- APEX Knee System EC-35051PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Knee System EP-20412PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX Knee System KR-46000Orthopedic manual surgical instrument1 report
- APEX Knee System KC-35043PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System KC-36023PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System KC-36053PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System KC-36063PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System KC-1101L-HPPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System KC-2202L-HPPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System KC-2203R-HPPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-40388PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35020PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35021PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35030PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35031PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35032PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35040PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35041PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-35053PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-36032PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-36040PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-36041PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EC-36052PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System KC-2801RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX Knee System EP-20211PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent APEX Knee System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 13, 2026Unstable
A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6) 2026. The original surgery date is (b)(6) 2026. 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 50233180 ↗InjuryJul 27, 2026Loosening of Implant Not Related to Bone-Ingrowth
A complaint was initiated for a patient who underwent a bi lateral knee revision surgery on (b)(6) 2026. The original surgery date is (b)(6) 2024. The reason for revision is reported patella loosening. During the revision both petella were removed and replaced.
Patient problems: Aseptic loosening
MAUDE report 50034094 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 25255161 ↗InjuryMay 22, 2026Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE (B)(6) 2026. THE REASON FOR REVISION IS REPORTED SUSPECTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 25255160 ↗InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE IS ON (B)(6) 2025. THE REASON FOR REVISION IS REPORTED LIMITED RANGE OF MOTION. DURING THE REVISION, THE TIBIAL TRAY AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANT.
Patient problems: Loss of Range of Motion
MAUDE report 25134879 ↗InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE FEMUR, TIBIAL TRAY, INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Implant Pain
MAUDE report 25014620 ↗InjuryApr 16, 2026Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE IS (B)(6) 2025. THE REASON FOR REVISION IS REPORTED SYNOVITIS. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Tissue Irritation
MAUDE report 24894416 ↗InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE (B)(6) 2024. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 24590162 ↗InjuryJan 26, 2026Unstable
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE IS (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 24176454 ↗InjuryJan 19, 2026Appropriate Device Problem Term/Code Not Available
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 24109041 ↗InjuryJan 19, 2026Patient Device Interaction Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 24108961 ↗InjuryJan 7, 2026Appropriate Device Problem Term/Code Not Available
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE ON (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 23988556 ↗InjuryNov 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE FEMUR, TIBIAL TRAY, TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 23655869 ↗InjuryNov 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2024. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 23495598 ↗InjurySep 18, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2025. THE ORIGINAL SURGERY DATE (B)(6) 2025. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION THE FEMUR, TIBIAL BASEPLATE, PETALLA, TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 23083096 ↗
Other Omni Life Science, Inc. products
- OMNI Knee78 models · 476 reports
- APEX PS Knee63 models · 170 reports
- OMNI Hip31 models · 68 reports
- APEX CR Knee28 models · 65 reports
- OMNI K2 Hip5 models · 8 reports · 1 recall
- OMNI ARC Hip10 models · 53 reports
- OMNI Interface Acetabular System22 models · 42 reports
- APEX Revision Knee22 models · 32 reports
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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