R3 0 HOLE HA CTD ACET SHELL 50MM 71332250

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 2020-03-11 for R3 0 HOLE HA CTD ACET SHELL 50MM 71332250 manufactured by Smith & Nephew, Inc..

Event Text Entries

[183106223] It was reported that during surgery the cup was impacted. The liner was placed and it sat down to where it should normally sit and was impacted without issue. The surgeon then went on to prepare the stem in his usual manner. When the trial reduction was done the r3 cup spun out of position. The surgeon said that the patient's acetabulum was very poor bone and the repeated attempts to impact the liner in the cup had made the bone too soft to hold the shell properly. He asked for a 3 hole r3 50mm cup to be opened and this was successfully implanted with 2 x 40mm screws. The same liner was removed from the no hole cup and successfully impacted into the 3 hole cup.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1020279-2020-00838
MDR Report Key9821172
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-11
Date of Report2020-03-11
Date of Event2019-03-18
Date Mfgr Received2019-03-18
Device Manufacturer Date2015-04-27
Date Added to Maude2020-03-11
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
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 NameR3 0 HOLE HA CTD ACET SHELL 50MM
Generic NamePROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUS
Product CodeMBL
Date Received2020-03-11
Catalog Number71332250
Lot Number15DM17555
OperatorHEALTH PROFESSIONAL
Device Availability*
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
101. Required No Informationntervention 2020-03-11

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