EXP ACETABULAR SHELL AND LINER SC3349-36-5456

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-03-06 for EXP ACETABULAR SHELL AND LINER SC3349-36-5456 manufactured by Stelkast Inc..

Event Text Entries

[101616926] An evaluation of the device cannot be performed as the device was not returned. The evidence suggests that this is not a device related incident.
Patient Sequence No: 1, Text Type: N, H10


[101616927] Patient presented for hip revision surgery because of hip dislocation.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2530191-2018-00029
MDR Report Key7317125
Report SourceCOMPANY REPRESENTATIVE
Date Received2018-03-06
Date of Report2018-03-06
Date of Event2018-02-21
Date Mfgr Received2018-02-26
Device Manufacturer Date2012-02-01
Date Added to Maude2018-03-06
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 ContactMR. JOHN REYHER
Manufacturer Street200 HIDDEN VALLEY ROAD
Manufacturer CityMCMURRAY PA 15317
Manufacturer CountryUS
Manufacturer Postal15317
Manufacturer Phone7249416368
Manufacturer G1STELKAST INC.
Manufacturer Street200 HIDDEN VALLEY ROAD
Manufacturer CityMCMURRAY PA 15317
Manufacturer CountryUS
Manufacturer Postal Code15317
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameEXP ACETABULAR SHELL AND LINER
Generic Name36MM HOODED EXP LINER
Product CodeMAY
Date Received2018-03-06
Model NumberSC3349-36-5456
Lot Number38960220201
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSTELKAST INC.
Manufacturer Address200 HIDDEN VALLEY ROAD MCMURRAY PA 15317 US 15317


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2018-03-06

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