FDA.reportPublic FDA data

MAUDE MDR 9603659

MDR report key
9603659
Report number
1020279-2020-00317
Event key
0
Event type
3
Date of event
2019-11-13
Date received
2020-01-17
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 IMPLANT IMPACTORPROSTHESISHIPFMRALCMPNNTCMNTDMTALSMITH & NEPHEW, INC.JDG7144000571440005UNKNOWNR *

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-170

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT DURING A TKA PROCEDURE, IMPACTOR WAS DEFECTIVE AND WILL NOT ATTACH TO THE LEGION IMPLANTS. NO DELAY. SURGEON HAD TO PUT THE IMPLANT BY HAND SINCE THERE WAS NO BACKUP DEVICE AVAILABLE. NO INJURY OR IMPACT TO PATIENT REPORTED.