FDA.reportPublic FDA data

MAUDE MDR 1815404

MDR report key
1815404
Report number
2249697-2010-01116
Event key
0
Event type
3
Date of event
2010-07-21
Date received
2010-08-19
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
JADWIGA DEGRADO
Address
325 CORPORATE DR. MAHWAH NJ 07430 US
Phone
201-201-2018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BOX CHISELINSTRUMENTSTRYKER ORTHOPAEDICS MAHWAHKDGNA6541-4-709PYKJFR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-08-1901. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT, "REP WAS FOLLOWING UP WITH (B)(6) ON (B)(6) 2010 AND DR MENTIONED THAT HE NOTICED DURING THE PROCEDURE, WHILE CUTTING THE FEMORAL BOX, THAT THERE WAS A CRACK IN THE MEDIAL FEMORAL CONDYLE (BONE). THIS WAS NOT DUE TO THE IMPLANTS, OR ANY OTHER STRYKER PRODUCT. DR RELATED IT TO A SMALL FEMUR AND HARD BONE. DR SPOKE TO REP AND BOTH DECIDED TO REPORT THE INCIDENT, JUST TO GET IT ON RECORD. USED 6.5 PARTIALLY THREADED SCREW TO SECURE THE BONE AND IMPLANTED THE COMPONENTS IN A NORMAL FASHION."

N

Patient 1

AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF DEVICE OR ADDITIONAL INFORMATION BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.