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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-CONSTRAINED
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED Back to Search Results
Catalog Number 74027232
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that patient underwent revision surgery due to infection.
 
Additional Manufacturer Narrative
The associated complaint device was not returned for evaluation.Please see the attached file for the results of our investigation.(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-CONSTRAINED
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6975931
Report Number1020279-2017-00909
Device Sequence Number10957743
Product Code JWH
UDI-Device Identifier00885556179062
UDI-Public00885556179062
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K111711
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2017
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 12/15/2017
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 Date04/20/2026
Device Catalogue Number74027232
Device Lot Number16DM16643
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 10/10/2017
Supplement Date Received by Manufacturer10/10/2017
10/10/2017
Initial Report FDA Received Date10/25/2017
Supplement Report FDA Received Date11/16/2017
12/15/2017
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 Age70 YR
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