FDA.reportPublic FDA data

MAUDE MDR 9720108

MDR report key
9720108
Report number
1020279-2020-00597
Event key
0
Event type
3
Date of event
2020-01-11
Date received
2020-02-18
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
1R3 3 HOLE ACET SHELL MM46PROSTHESIS, HIP, SEMI-CONSTRAINED, UNCEMENTED, METAL/POLYMER, POROUSSMITH & NEPHEW, INC.MBL713355467133554617DM14703N *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-180

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A THR PROCEDURE, THE R3 XLPE POLY LINER DID NOT LOCK R3 ACETABULAR CUP AND WHILE WE WERE TRYING TO REMOVE THE ACETABULAR CUP AND THE SCREWS OF THE ACETABULUM GOT DAMAGED. DUE TO WHICH WE COULD NOT OPERATE FURTHER.