OMNI KneeRecalls & reported problems across all models
Omni Life Science, Inc. · 78 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 476
- Deaths reported
- 0
- Injuries reported
- 476
- Recalls
- 0
We found 78 models of OMNI Knee by Omni Life Science, Inc. in the FDA's device registry (GUDID). Together they are named in 476 adverse event reports in the FDA's MAUDE database, received between Feb 6, 2017 and Sep 28, 2026 — classified as 476 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (174 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 OMNI Knee problems
Device problems
- Insufficient Device Problem Information174
- Appropriate Device Problem Term/Code Not Available134
- Adverse Event Without Identified Device or Use Problem59
- Unstable42
- Loosening of Implant Not Related to Bone-Ingrowth20
- Loose or Intermittent Connection17
- Patient Device Interaction Problem8
- Contamination5
Patient problems
- Unspecified Infection190
- No Code Available49
- Pain47
- Fall39
- Insufficient Information31
- No Known Impact Or Consequence To Patient22
- Joint Laxity21
- No Information15
OMNI Knee models
78 models, most reported first. Each model has its own page with its reports, recalls and device details.
- OMNI Knee KC-36040PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER26 reports
- OMNI Knee KC-36050PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- OMNI Knee KC-36030PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER20 reports
- OMNI Knee KC-36020PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER19 reports
- OMNI Knee KC-35040PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER17 reports
- OMNI Knee KC-2203RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- OMNI Knee KC-36032PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER16 reports
- OMNI Knee KC-36031PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER15 reports
- OMNI Knee KC-40328PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER14 reports
- OMNI Knee KC-35050PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER13 reports
- OMNI Knee KC-2202RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- OMNI Knee KC-36022PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- OMNI Knee KC-36042PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER12 reports
- OMNI Knee KC-35030PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- OMNI Knee KC-36034PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- OMNI Knee KC-36052PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER11 reports
- OMNI Knee KC-2204RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- OMNI Knee KC-35032PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- OMNI Knee KC-35041PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- OMNI Knee KC-36060PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER10 reports
- OMNI Knee KC-2203LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- OMNI Knee KC-35020PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- OMNI Knee KC-36024PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- OMNI Knee KC-36041PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- OMNI Knee KC-36044PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER9 reports
- OMNI Knee KC-35042PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- OMNI Knee KC-35060PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- OMNI Knee KC-40358PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER8 reports
- OMNI Knee KC-36021PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER7 reports
- OMNI knee KC-2204LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- OMNI Knee KC-36026PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- OMNI Knee KC-36051PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- OMNI Knee KC-36062PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER6 reports
- OMNI Knee KC-35052PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- OMNI Knee KC-36054PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- OMNI Knee KC-40388PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER5 reports
- OMNI Knee KC-35031PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- OMNI Knee KC-36036PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- OMNI Knee KC-36046PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- OMNI Knee KC-36056PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- OMNI Knee KC-40298PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER4 reports
- OMNI Knee KC-2202LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- OMNI Knee KC-2205LPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- OMNI Knee KC-2205RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- OMNI Knee KC-35022PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- OMNI Knee KC-35062PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER3 reports
- OMNI Knee KC-35021PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-35024PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-35034PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-35036PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-35044PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-35051PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-36038PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-36039PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-36059PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER2 reports
- OMNI Knee KC-2206RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-35012PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-35026PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-35054PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-35061PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-35064PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36010PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36011PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36014PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36018PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36048PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36049PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36058PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36061PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-36066PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-40350PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-40380PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-37030PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-37041PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-2303RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-2304RPROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-2404RPROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
- OMNI Knee KC-27030PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER1 report
Recent OMNI Knee adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 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 is dated (b)(6) 2026. The reason for revision is reported ruptured quad tendon. Surgeon previously performed a total knee on the Patient and decided to swap the poly and bolt as a precaution. During the revision the tibial insert and retaining bolt were removed and replaced with a new implants.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 50913157 ↗InjuryAug 6, 2026Break
We were notified on 11/Jul/2026 of a planned suregry due to tibial tray breakage. Revison surgery has not taken place as of this report.
Patient problems: Failure of Implant
MAUDE report 50161235 ↗InjuryJul 27, 2026Implant subsidence
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 failed/collapsed medial and anterior tibia component do to patient falls. During the revision the tibial tray, insert and bolt were removed and replaced with new devices.
Patient problems: Fall
MAUDE report 50013350 ↗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 ON (B)(6) 2024. THE REASON FOR REVISION IS REPORTED PATIENT PAIN. DURING THE REVISION, THE TIBIAL TRAY, INSERT AND RETAINING BOLT WERE REMOVED AND REPLACED WITH NEW IMPLANTS.
Patient problems: Implant Pain
MAUDE report 25014226 ↗InjuryApr 8, 2026Loosening of Implant Not Related to Bone-Ingrowth
A COMPLAINT WAS INITIATED FOR A PATIENT WHO UNDERWENT A KNEE REVISION SURGERY ON (B)(6) 2026. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. 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 24814651 ↗InjuryMar 24, 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) 2021. 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 24673107 ↗InjuryFeb 27, 2026Unstable
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) 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 24468982 ↗InjuryJan 26, 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 IS (B)(6) 2025. THE REASON FOR REVISION IS REPORTED TIGHT JOINT. DURING THE REVISION, THE TIBIAL TRAY, INSERT, BOLT AND PATELLA WERE REMOVED AND REPLACED WITH NEW IMPLANT.
Patient problems: Joint Contracture
MAUDE report 24176520 ↗InjuryJan 5, 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) 2019. 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 23956701 ↗InjuryDec 22, 2025Loosening 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) 2025. THE ORIGINAL SURGERY DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE PETALLA, INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS.
Patient problems: Aseptic loosening
MAUDE report 23862588 ↗InjuryDec 15, 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) 2020. 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 23802052 ↗InjuryAug 13, 2025Loosening 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) 2025. THE ORIGINAL SURGERY IS DATED (B)(6) 2024. THE REASON FOR REVISION IS REPORTED LOOSENING. DURING THE REVISION THE PATELLA BUTTON WAS REMOVED AND REPLACED WITH A NEW IMPLANT.
Patient problems: Aseptic loosening
MAUDE report 22793611 ↗InjuryJul 23, 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) 2020. THE ORIGINAL SURGERY DATE IS (B)(6) 2019. THE REASON FOR REVISION IS REPORTED PAIN WITH HEMARTHROSIS. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THIS EVENT WAS REPORTED TO CORIN'S CLINICAL DEPARTMENT ON 7/17/2025 THRU (B)(4).
Patient problems: Pain
MAUDE report 22574415 ↗InjuryJul 22, 2025Loosening 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) 2021. THE ORIGINAL SURGERY DATE IS (B)(6) 2018. THE REASON FOR REVISION IS REPORTED INSTABILITY. DURING THE REVISION THE INSERT AND BOLT WERE REMOVED AND REPLACED WITH NEW COMPONENTS. THIS EVENT WAS REPORTED TO CORIN'S CLINICAL DEPARTMENT ON (B)(6) 2025 UNDER CASE STUDY (B)(6).
Patient problems: Joint Laxity
MAUDE report 22563941 ↗InjuryJul 10, 2025Loosening 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) 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 22468088 ↗
Other Omni Life Science, Inc. products
- 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 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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