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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 3 LT; PROST, KNEE, PATELLOFEM, SEMI-CON, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JRNY II XR BASEPLATE SZ 3 LT; PROST, KNEE, PATELLOFEM, SEMI-CON, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 74022203
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Injury (2348)
Date of Event 01/10/2019
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that the clinical subject experienced left knee hemarthrosis and cellulitis.The event was resolved via revision surgery.The event is considered ongoing.
 
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Brand Name
JRNY II XR BASEPLATE SZ 3 LT
Common Device Name
PROST, KNEE, PATELLOFEM, SEMI-CON, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9997221
Report Number1020279-2020-01372
Device Sequence Number3836137
Product Code JWH
UDI-Device Identifier00885556615331
UDI-Public00885556615331
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K152726
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source health professional,study,use
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 12/15/2020
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 Number74022203
Device Catalogue Number74022203
Device Lot Number17ASL0004B
Initial Date Received by Manufacturer 04/02/2020
Supplement Date Received by Manufacturer12/13/2020
Initial Report FDA Received Date04/24/2020
Supplement Report FDA Received Date12/16/2020
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;
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