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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 KP-0425L
Health Effect - Clinical Code No Code Available (3191)
Date of Event 03/11/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The complainant made no indication of any omnilife science device malfunction or deficiency related to the identity, quality, durability, reliability, safety, effectiveness or device performance contributing 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 unknown.The reason for revision is reported loosening.During the revision, the original tibial insert and femoral component were removed and replaced with 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 Key9964223
Report Number1226188-2020-00073
Device Sequence Number2740032
Product Code JWH
UDI-Device Identifier00841690112761
UDI-Public00841690112761
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K112891
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 04/15/2020
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 Model NumberKP-0425L
Device Catalogue NumberKP-0425L
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 04/09/2020
Initial Report FDA Received Date04/15/2020
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 Age60 YR
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