REF THREE HOLE SHELL 50MM 71336450

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-12-24 for REF THREE HOLE SHELL 50MM 71336450 manufactured by Smith & Nephew, Inc..

Event Text Entries

[177211166] It was reported that during a thr surgery, the doctor prepared acetabulum and took a trial of cup size 50. It was good and fixed well so he took the original reflection shell and it fixed well. He then put a 25mm screw for better fixation, then fixed liner for 32 mm head. Later he prepared the femur fix stem and took trial for the head and reduced the hip joint. When he dislocated the hip to put the original head reflection shell, the liner came out and the screw remained inside the bone (it was later removed). He tried to fix it again but did not succeed and then he took size 54 mm. This caused a delay of 30 minutes to an hour.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2019-04587
MDR Report Key9517163
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2019-12-24
Date of Report2020-03-12
Date of Event2019-11-26
Date Mfgr Received2020-03-09
Device Manufacturer Date2019-08-07
Date Added to Maude2019-12-24
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 NameREF THREE HOLE SHELL 50MM
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Product CodeMBL
Date Received2019-12-24
Model Number71336450
Catalog Number71336450
Lot Number19HM06387
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
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
10 2019-12-24

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