FDA.reportPublic FDA data

MAUDE MDR 3658519

MDR report key
3658519
Report number
1020279-2014-00130
Event key
0
Event type
3
Date of event
2014-01-22
Date received
2014-03-04
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MRS. MELANIE TRAVIS
Address
1450 BROOKS ROAD MEMPHIS TN 38116 US
Phone
901-901-9013
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PLUSFEMORAL COMPONENTSMITH & NEPHEW, INC.LPF7653538206GT99728R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-04713390481. H

Event Narratives#

N

Patient 1

THE PURPOSE OF THIS INVESTIGATION WAS TO EXAMINE THE AS-RECEIVED COMPONENTS. THE RETURNED HIP STEM, CERAMIC FEMORAL HEAD, ACETABULAR LINER, AND REFLECTION ACETABULAR SHELL WERE EXAMINED VISUALLY. NO DESTRUCTIVE TESTING WAS CARRIED OUT. THE STEM HAD SIGNS OF BURNISHING AND FRETTING ALONG THE LENGTH OF THE STEM. THE CERAMIC FEMORAL HEAD HAD SIGNS OF METAL TRANSFER AND MATERIAL REMOVAL. THE REFLECTION ACETABULAR SHELL HAD SIGNS OF BURNISHING ON THE TAPER LOCKING SURFACE WHICH WAS LIKELY DUE TO CONTACT WITH CERAMIC FEMORAL HEAD OR THE HIP STEM FOLLOWING THE FRACTURE OF THE LINER. THE CERAMIC ACETABULAR LINER WAS FRACTURED IN TWO PIECES AND A PORTION OF THE RIM WAS MISSING FROM ONE OF THE FRAGMENTS. IT IS UNCLEAR THE CAUSE OF THE FRACTURED LINER.

D

Patient 1

IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED.

N

Patient 1