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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OMNILIFE SCIENCE, INC. APEX KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIA
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OMNILIFE SCIENCE, INC. APEX KNEE SYSTEM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIA Back to Search Results
Model Number KC-36050
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 07/09/2020
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 is (b)(6) 2017.The reason for revision is reported infection.During the revision, they removed the original tibial insert and locking bolt and replaced them with new components.
 
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Brand Name
APEX KNEE SYSTEM
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIA
Manufacturer (Section D)
OMNILIFE SCIENCE, INC.
480 paramount drive
raynham, ma
MDR Report Key10290733
Report Number1226188-2020-00126
Device Sequence Number14297009
Product Code JWH
UDI-Device Identifier00841690101734
UDI-Public00841690101734
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K060192
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 07/17/2010
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 Date12/31/2021
Device Model NumberKC-36050
Device Catalogue NumberKC-36050
Device Lot Number25608
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/10/2020
Initial Report FDA Received Date07/17/2020
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 Age77 YR
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