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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-36030
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Pain (1994)
Date of Event 08/04/2020
Type of Reportable Event Serious Injury
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) 2018.The reason for revision is reported patient pain.During the revision, surgeon replaced the tibial insert and retaining bolt.
 
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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 Key10445344
Report Number1226188-2020-00141
Device Sequence Number2795838
Product Code JWH
UDI-Device Identifier00841690101871
UDI-Public00841690101871
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K060192
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 08/24/2020
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 Date02/27/2023
Device Model NumberKC-36030
Device Catalogue NumberKC-36030
Device Lot Number29304
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 08/05/2020
Initial Report FDA Received Date08/24/2020
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 Age66 YR
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