FORTE 71338954

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2012-03-13 for FORTE 71338954 manufactured by Smith And Nephew - Germany.

Event Text Entries

[2548179] It was reported that a revision surgery was performed due to implant breakage.
Patient Sequence No: 1, Text Type: D, B5


[9753666] .
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1020279-2012-00141
MDR Report Key2489887
Report Source*
Date Received2012-03-13
Date of Report2012-03-12
Date of Event2012-03-12
Date Mfgr Received2012-03-12
Device Manufacturer Date2009-06-01
Date Added to Maude2012-03-13
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
Manufacturer StreetALEMANNENSTRASSSE 14
Manufacturer CityTUTTLINGEN 78532
Manufacturer CountryGM
Manufacturer Postal Code78532
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFORTE
Generic NameACETABULAR LINER
Product CodeLPF
Date Received2012-03-13
Catalog Number71338954
Lot Number09FT33140
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerSMITH AND NEPHEW - GERMANY
Manufacturer AddressALEMANNENSTRASSSE 14 TUTTLINGEN 78532 GM 78532


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2012-03-13

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