MAUDE MDR 554174

MDR report key
554174
Report number
MW1033586
Event key
0
Event type
3
Date of event
2004-08-09
Date received
2004-09-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LIFENETCADAVER GRAFT*LMOUNOS #03-4508-004**YN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-09-1301. H

Event Narratives#

D

Patient 1

THE PT HAD AN ACL RECONSTRUCTION OF THE RIGHT KNEE WITH A CADAVER GRAFT. A COUPLE OF DAYS PRIOR TO ADMISSION PT WAS NOT FEELING WELL, HAD SOME INCREASED SWELLING AND PAIN. TWO DAYS PRIOR TO ADMISSION, PT WAS PUT ON DURICEF. ON THE DAY OF ADMISSION, PT WOKE UP WITH EXCRUCIATING PAIN IN THE RIGHT KNEE AND WENT TO THE DR'S OFFICE. PT WAS ADMITTED AND TAKEN TO SURGERY FOR INCISION AND DRAINAGE; THE GRAFT WAS VISUALIZED AND LOOKED FINE. PT WAS SUBSEQUENTLY DISCHARGED HOME THE NEXT DAY WITH ORDER FOR IV ROCEPHIN. CULTURES GREW OUT SERRATIA. THE PT WAS READMITTED THE NEXT DAY AND HAD ANOTHER INCISION AND DRAINAGE THE FOLLOWING DAY. PT WAS DISCHARGED HOME THE NEXT DAY TO CONTINUE ON IV ZOSYN. APPROX 40 HOURS PRIOR TO READMISSION ON 15 DAYS LATER, PT STARTED TO SPIKE TEMPERATURES, BUT NO KNEE PAIN. OF CONCERN AT THAT POINT WAS LOW WHITE COUNT OF 1.7. PT PICC LINE WAS EXAMINED WITH NO EVIDENCE OF ANY AREA OF ERYTHEMA OR DRAINAGE. THE INFECTIOUS DISEASE PHYSICIAN'S IMPRESSION WAS FEVER LEUKOPENIA, RULE OUT BONE MARROW SUPPRESSION SECONDARY TO THE ANTIOBIOTIC ZOSYN. PT WAS SUBSEQUENTLY DISCHARGED 2 DAYS LATER, AGAIN ON IV ROCEPHIN.