FDA.reportPublic FDA data

MAUDE MDR 445387

MDR report key
445387
Report number
445387
Event key
0
Event type
3
Date of event
2003-02-20
Date received
2003-02-28
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#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CARTICELCARTILAGE IMPLANTGENZYME TISSUE REPAIRNCONININIYN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-02-2801. R

Event Narratives#

D

Patient 1

PT HAD SURGERY FOR ANTEROMEDIALIZATION AND BIPOLAR PATELLOFEMORAL AUTOLOGOUS-CULTURED CHONDROCYTE IMPLANTATION DEEP MICROSUTURE PERIOSTEAL PATCHES. THE NEXT DAY DEVELOPED FEVER, PAIN, AND ELEVATED WHITE COUNT TO 27,000. DIAGNOSED AS SEPTIC JOINT IN OPERATIVE KNEE. OPEN DEBRIDEMENT AND REMOVAL OF THE CARTICEL CELLS IMPLANT ONE DAY LATER.

D

Patient 1

ADD'L INFO RECEIVED FROM MFR 4-3-03: LETTER CONTAINS INFO CONCERNING AN ADVERSE EVENT EXPERIENCED AFTER IMPLANTATION OF CARTICEL (AUTOLOGOUS CULTURED CHONDROCYTES). GENZYMES BIOSURGERY MANUFACTURES CARTICEL UNDER A BIOLOGICS LICENSE APPLICATION AND ADVERSE EVENT REPORTS ARE SUBMITTED PER 21 CFR 600.80. THE INFO THEY RECEIVED REGARDING THE REFERENCED EVENT WAS SUBMITTED TO THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH ON MARCH 11, 2003 ON MEDWATCH FORM 3500A.