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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR Back to Search Results
Catalog Number 74027232
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code Joint Swelling (2356)
Date of Event 10/07/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a total knee arthroplasty was performed on the right knee for patellar component and poly exchange due to knee pain, leg pain, associated swelling and loosening of internal prosthesis right knee.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation please review attached for investigation results.(b)(4).
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM
Common Device Name
PROSTHESIS,KNEE,PATELLOFEMOROTIBIAL,SEMI-CONSTRAIND,CMNTD,POLYMR/MTAL/POLYMR
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key7035674
Report Number1020279-2017-01032
Device Sequence Number126874
Product Code JWH
UDI-Device Identifier00885556179062
UDI-Public00885556179062
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date (Section B) 03/09/2018
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 Date10/22/2023
Device Catalogue Number74027232
Device Lot Number13KM18642
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 11/06/2017
Supplement Date Received by Manufacturer11/06/2017
11/06/2017
11/06/2017
Initial Report FDA Received Date11/15/2017
Supplement Report FDA Received Date11/26/2017
11/30/2017
03/09/2018
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 Other; Required Intervention;
Patient Age64 YR
Patient Weight85
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