R3 71338952

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-04-14 for R3 71338952 manufactured by Smith And Nephew, Inc..

Event Text Entries

[1868381] It was reported that a revision surgery was performed.
Patient Sequence No: 1, Text Type: D, B5


[9108169] In the initial mdr, it was reported (b)(4) as the legal manufacturer. This information is incorrect. The legal manufaturer should be 8010764, our germany manufacturer site.
Patient Sequence No: 1, Text Type: N, H10


[9113000] .
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1020279-2011-00130
MDR Report Key2055194
Report Source05,07
Date Received2011-04-14
Date of Report2011-04-13
Date of Event2011-04-06
Date Mfgr Received2011-03-21
Device Manufacturer Date2009-12-01
Date Added to Maude2011-04-14
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 FDA0
Event Location0
Manufacturer ContactMR PHILLIP EMMERT
Manufacturer Street1450 E. BROOKS RD
Manufacturer CityMEMPHIS TN 38116
Manufacturer CountryUS
Manufacturer Postal38116
Manufacturer Phone9013995296
Manufacturer G1SMITH AND NEPHEW (GERMANY) ORTHOPAEDICS
Manufacturer StreetALEMANNENSTRASSE 14
Manufacturer CityTUTTLINGEN TN 38116785
Manufacturer CountryGM
Manufacturer Postal Code38116 7853
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameR3
Generic NameACETABULAR SHELL
Product CodeLPF
Date Received2011-04-14
Catalog Number71338952
Lot Number09MT38082
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH AND NEPHEW, INC.
Manufacturer Address1450 BROOKS ROAD MEMPHIS TN 38116 US 38116


Patients

Patient NumberTreatmentOutcomeDate
10 2011-04-14

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