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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-36032
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/10/2020
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 is (b)(6) 2011.During the revision a poly swap occurred replacing the tibial insert and retaining bolt.
 
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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 Key9850176
Report Number1226188-2020-00055
Device Sequence Number765509
Product Code JWH
UDI-Device Identifier00841690101611
UDI-Public00841690101611
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K060192
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 03/18/2020
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 Date05/01/2015
Device Model NumberKC-36032
Device Catalogue NumberKC-36032
Device Lot Number6685
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/10/2020
Initial Report FDA Received Date03/18/2020
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 Age51 YR
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