JOURNEY PFJ IMPLANT X-SM RT 71461011

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-18 for JOURNEY PFJ IMPLANT X-SM RT 71461011 manufactured by Smith & Nephew, Inc..

Event Text Entries

[139102089]
Patient Sequence No: 1, Text Type: N, H10


[139102090] It was reported that the implant was revised due to disease progression, not implant failure. No more information available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2019-01084
MDR Report Key8429570
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-03-18
Date of Report2019-06-20
Date of Event2019-02-22
Date Mfgr Received2019-02-22
Date Added to Maude2019-03-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR. SARAH FREESTONE
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone0447940038
Manufacturer G1SMITH & NEPHEW, INC.
Manufacturer Street1450 BROOKS ROAD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal Code38116
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameJOURNEY PFJ IMPLANT X-SM RT
Generic NamePROSTHESIS, KNEE, PATELLO/FEMORAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
Product CodeKRR
Date Received2019-03-18
Catalog Number71461011
OperatorHEALTH PROFESSIONAL
Device Availability*
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITH & NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2019-03-18

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