APEX CR KneeRecalls & reported problems across all models
Omni Life Science, Inc. · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 65
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls
- 0
We found 28 models of APEX CR Knee by Omni Life Science, Inc. in the FDA's device registry (GUDID). Together they are named in 65 adverse event reports in the FDA's MAUDE database, received between Feb 17, 2017 and Aug 4, 2026 — classified as 64 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (22 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 CR Knee problems
Device problems
- Insufficient Device Problem Information22
- Adverse Event Without Identified Device or Use Problem11
- Appropriate Device Problem Term/Code Not Available10
- Unstable9
- Loosening of Implant Not Related to Bone-Ingrowth5
- Loose or Intermittent Connection4
- Patient Device Interaction Problem3
- Patient-Device Incompatibility2
Patient problems
- Unspecified Infection12
- No Code Available9
- Pain8
- Failure of Implant6
- Fall6
- Joint Laxity5
- No Known Impact Or Consequence To Patient5
- Insufficient Information4
APEX CR Knee models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- APEX CR Knee KC-1145LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- APEX CR Knee KC-1104LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- APEX CR Knee KC-1105RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- APEX CR Knee KC-1135RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- APEX CR Knee KC-1145RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- APEX CR Knee KC-1102LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1103RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1105LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1420LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1445RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1450LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1450RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1460LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- APEX CR Knee KC-1101LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX CR Knee KC-1104RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX CR Knee KC-1425LPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- APEX CR Knee KC-1430RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- APEX CR Knee KC-1440RPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER2 reports
- APEX CR Knee KC-1101RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1102RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1103LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1106RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1125RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-53000PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1420RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1425RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1445LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- APEX CR Knee KC-1460RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent APEX CR Knee adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 4, 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) 2021. The reason for revision is reported instability. During the revision the femur, tibial tray, insert and bolt were removed and replaced with new components.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50127095 ↗InjuryJun 15, 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 IS (B)(6) 2021. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE FEMUR, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Aseptic loosening
MAUDE report 25501512 ↗InjuryNov 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information
UNBEARABLE PAIN 18 DAYS POST SURGERY FOLLOWING AN APEX TOTAL KNEE REPLACEMENT.
Patient problems: Implant Pain
MAUDE report 23665998 ↗InjuryJul 22, 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 TIBIAL INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 22564113 ↗InjuryApr 29, 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) 2013. THE REASON FOR REVISION IS REPORTED INFECTION. DURING THE REVISION ALL IMPLANTS REMOVED AND REPLACED WITH CEMENT SPACER (1ST STAGE REVISION).
Patient problems: Bacterial Infection
MAUDE report 21925079 ↗InjuryNov 22, 2024Adverse 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) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2023. THE REASON FOR REVISION IS INFECTION. DURING THE REVISION ALL OMNI IMPLANTS WERE REMOVED AND REPLACED WITH NON-OMNI IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 20757504 ↗InjuryNov 5, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON 10/21/2024. THE ORIGINAL SURGERY IS DATED (B)(6) 2016. THE REASON FOR REVISION IS REPORTED LOOSENING AFTER PATIENT FALL. DURING THE REVISION THE FEMUR, INSERT AND BOLT WE REMOVED AND REPLACED WITH A NEW IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 20608561 ↗InjuryJun 25, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE FEMUR, TIBIAL TRAY, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW REVISION COMPONENTS.
Patient problems: Joint Laxity
MAUDE report 19603928 ↗InjuryMay 6, 2024No Apparent Adverse Event; No Apparent Adverse Event
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2024. THE ORIGINAL SURGERY IS DATED 03/30/2023. THE REVISION SURGERY OCCURRED BECAUSE OF METAL ALLERGY. DURING THE REVISION ALL IMPLANTS WERE REMOVED AND REPLACED.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 19247007 ↗InjuryApr 23, 2024Adverse 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) 2024. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. THE REASON FOR REVISION IS REPORTED INSTABILITY OF THE MEDIAL COLLATERAL LIGAMENT. DURING THE REVISION THE FEMUR, TIBIAL TRAY, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Joint Laxity
MAUDE report 19164491 ↗InjuryDec 20, 2023Adverse 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) 2023. THE ORIGINAL SURGERY DATE IS (B)(6) 2020. THE REASON FOR REVISION IS INFECTION. DURING THE ORIGINAL IMPLANTS WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 18370352 ↗InjuryDec 10, 2023Adverse 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)23. THE REASON FOR REVISION IS AN INFECTION. FILED UNDER MDR 1226188-2023-00108. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. DURING THE REVISION, ALL IMPLANTS WERE REMOVED AND REPLACED WITH NON CORIN IMPLANTS.
Patient problems: Unspecified Infection
MAUDE report 18298652 ↗InjuryMar 13, 2023Adverse 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) 2023. THE ORIGINAL SURGERY DATE IS (B)(6) 2022. THE REASON FOR REVISION IS REPORTED TIGHT JOINT. DURING THE REVISION, THE KNEE WAS MANUALLY MANIPULATED UNDER ANESTHESIA TO HELP RELIEVE THE STIFFNESS IN THE JOINT.
Patient problems: Joint Contracture
MAUDE report 16527333 ↗InjuryJan 26, 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 ORIGINAL SURGERY IS DATED (B)(6) 2019. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE FEMUR, TIBIAL INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH A NEW IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 16251162 ↗InjuryOct 4, 2022Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2022. THE ORIGINAL SURGERY IS DATED 06/17/2019. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE IMPLANTS, WAS REMOVED AND REPLACED WITH A NEW REVISION IMPLANTS.
Patient problems: Joint Laxity
MAUDE report 15538865 ↗
Other Omni Life Science, Inc. products
- OMNI Knee78 models · 476 reports
- APEX PS Knee63 models · 170 reports
- OMNI Hip31 models · 68 reports
- OMNI K2 Hip5 models · 8 reports · 1 recall
- OMNI ARC Hip10 models · 53 reports
- OMNI Interface Acetabular System22 models · 42 reports
- APEX Knee System30 models · 38 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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