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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY BCS II FEM COCR LT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
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SMITH & NEPHEW, INC. JRNY BCS II FEM COCR LT SZ 6; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL Back to Search Results
Catalog Number 74024926
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/10/2016
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that post tka patient developed left knee (b)(6) infection which was resolved with 2 weeks of bactrim ds therapy of unknown does.Severity of this event was deemed as moderate.
 
Additional Manufacturer Narrative
Corrections based on additional data received.
 
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Brand Name
JRNY BCS II FEM COCR LT SZ 6
Common Device Name
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key6844391
Report Number1020279-2017-00705
Device Sequence Number19232666
Product Code JWH
UDI-Device Identifier00885556611449
UDI-Public00885556611449
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source health professional,other,stu
Initial Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date (Section B) 04/02/2018
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 Date02/21/2026
Device Catalogue Number74024926
Device Lot Number01602875
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 08/10/2017
Supplement Date Received by Manufacturer09/07/2017
09/07/2017
Initial Report FDA Received Date09/06/2017
Supplement Report FDA Received Date09/19/2017
04/02/2018
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
JOURNEY TIBIA BASE NP LT SZ 5, 74022225/UNK LOT; JRNY BCS PAT BICONVEX 26 MM STD, 74024626/ UNK LOT; JRNY II BCS XLPE ART ISRT SZ5-6LT9MM, 74027261/UNK
Outcome Attributed to Adverse Event Other; Required Intervention;
Patient Age69 YR
Patient Weight107
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