FDA.reportPublic FDA data

MAUDE MDR 9511147

MDR report key
9511147
Report number
1020279-2019-04560
Event key
0
Event type
3
Date of event
2019-11-26
Date received
2019-12-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
DR. SARAH FREESTONE
Address
1450 BROOKS ROAD MEMPHIS TN 38116 US
Phone
44-44-0447
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FEMORAL HEAD/NECK IMPACTORPROSTH, HIP, SEMI-CONSTRA, UNCEMENT, METAL/POLY, NON-POROUS, CALICUM-PHOSPHATESMITH & NEPHEW, INC.MEH713600937136009317CM14260R *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-12-230

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A THR PROCEDURE, UPON IMPACTING THE HEAD ON TO THE FEMORAL IMPLANT THE IMPACTOR'S BLACK PLASTIC PART BROKE OVER THE INCISION. THE PIECE WAS FOUND AND NOTHING WAS LEFT IN THE PATIENT. THE HEAD WAS FIRMLY ATTACHED TO THE STEM. THERE WAS AN S&N BACKUP DEVICE AVAILABLE. THERE WERE NO DELAYS IN THE PROCEDURE AND NO PATIENT INJURY.