FDA.reportPublic FDA data

MAUDE MDR 2599968

MDR report key
2599968
Report number
0001825034-2012-00804
Event key
0
Event type
3
Date of event
2012-05-06
Date received
2012-06-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MS. ANGELA DICKSON
Address
56 EAST BELL DRIVE WARSAW IN 46582 US
Phone
574-574-5742
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1BIOMET TIBIAL LOCKING BARPROSTHESIS, KNEEBIOMET ORTHOPEDICSBSNN/A141205747020R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-06-0601. H; 2. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THAT PATIENT WITH A HISTORY OF INFECTION UNDERWENT KNEE REVISION ON (B)(6) 2012. A SUBSEQUENT REVISION PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO INFECTION. THE JOINT WAS WASHED OUT AND THE BEARING WAS REMOVED AND WASHED THEN REIMPLANTED. THE LOCKING BAR WAS REMOVED AND REPLACED. NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE.

N

Patient 1

THE USER FACILITY IS OUTSIDE OF THE UNITED STATES. NO MEDWATCH REPORT WAS RECEIVED. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. REVIEW OF STERILIZATION CERTIFICATION CONFIRMS DEVICE WAS STERILIZED IN ACCORDANCE WITH ISO 11137-2. THERE ARE WARNINGS IN THE PACKAGE INSERT THAT STATE THAT THIS TYPE OF EVENT CAN OCCUR: "EARLY OR LATE POSTOPERATIVE INFECTION AND ALLERGIC REACTION." THIS REPORT IS NUMBER 2 OF 2 MDRS FILED FOR THE SAME EVENT (REFERENCE 1825034-2012-00803 / 00804).