EXP ACETABULAR SHELL AND LINER SC3348-32MM +0

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 2019-01-21 for EXP ACETABULAR SHELL AND LINER SC3348-32MM +0 manufactured by Stelkast Inc..

Event Text Entries

[133695289] An evaluation of the device cannot be performed as the device was not returned.
Patient Sequence No: 1, Text Type: N, H10


[133695290] Stelkast was made aware of a revision surgery that required re-implantation of a replacement prosthetic hip.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2530191-2019-00003
MDR Report Key8264277
Report SourceCOMPANY REPRESENTATIVE
Date Received2019-01-21
Date of Report2019-01-21
Date of Event2018-08-01
Date Mfgr Received2019-01-11
Device Manufacturer Date2014-06-09
Date Added to Maude2019-01-21
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 NameBIOLOX DELTA FEMORAL HEAD
Product CodeMAY
Date Received2019-01-21
Model NumberSC3348-32MM +0
Lot Number31308-060914
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. Required No Informationntervention 2019-01-21

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