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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE INC. APEX KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
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OMNILIFE SCIENCE INC. APEX KNEE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL Back to Search Results
Model Number KC-40328
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 04/01/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Review of the manufacturing documentation and sterilization documentation for the devices in question revealed no deviation from process or non-conformity of product that would have caused or contributed to the adverse event.
 
Event or Problem Description
A complaint was initiated for a patient who underwent a knee revision surgery on (b)(6)2020.The original surgery date was (b)(6) 2015.The reason for revision is reported patellar fracture.During the revision, the original tibial insert, patella and retaining bolt were revised to new components.
 
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Brand Name
APEX KNEE
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL
Manufacturer (Section D)
OMNILIFE SCIENCE INC.
480 paramount dr.
raynham, ma
MDR Report Key9958895
Report Number1226188-2020-00072
Device Sequence Number14102308
Product Code JWH
UDI-Device Identifier00841690101956
UDI-Public00841690101956
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K060192
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2015
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/14/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date02/01/2020
Device Model NumberKC-40328
Device Catalogue NumberKC-40328
Device Lot Number20003
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/08/2020
Initial Report FDA Received Date04/14/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age54 YR
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