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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 6 PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER

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SMITH & NEPHEW, INC. JRNY UNI TIBIAL BASE RM/LL SZ 6 PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER Back to Search Results
Catalog Number 71422436
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 10/08/2018
Event Type  Injury  
Event Description

It was reported that a revision surgery was performed due to implant malfunction. Insert and tibial tray explanted. Back up available.

 
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Brand NameJRNY UNI TIBIAL BASE RM/LL SZ 6
Type of DevicePROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
MDR Report Key8030410
MDR Text Key125863446
Report Number1020279-2018-02348
Device Sequence Number1
Product Code HSX
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK102069
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/19/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/01/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number71422436
Device LOT Number16EM14449
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/18/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 11/01/2018 Patient Sequence Number: 1
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