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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; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
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SMITH & NEPHEW, INC. JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM; PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY Back to Search Results
Model Number 74027232
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Injury (2348)
Date of Event 04/03/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to pain.This issue was caused by synovitis.The insert was removed.Surgeon reported that the device was not defective.
 
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Brand Name
JRNY II BCS XLPE ART ISRT SZ 3-4-RT 10MM
Common Device Name
PROSTH, KNEE, PATELLOFEM, SEMI-CONS, CEMENTED, POLY/METAL/POLY
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key10003043
Report Number1020279-2020-01391
Device Sequence Number16667370
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 Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/16/2021
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 Number74027232
Device Catalogue Number74027232
Device Lot Number19BM02256
Initial Date Received by Manufacturer 04/03/2020
Supplement Date Received by Manufacturer08/13/2021
Initial Report FDA Received Date04/27/2020
Supplement Report FDA Received Date08/16/2021
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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