FDA.reportPublic FDA data

MAUDE MDR 2888843

MDR report key
2888843
Report number
1043534-2012-01727
Event key
0
Event type
3
Date received
2012-12-28
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#

Address
5677 AIRLINE ROAD ARLINGTON TN 38002 US
Phone
901-901-9018
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SWANSON FINGER JOINTSMALL JOINT COMPONENT, CODE:KWHWRIGHT MEDICAL TECHNOLOGY, INC.KWFNIR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-12-280

Event Narratives#

D

Patient 1

ALLEGEDLY, PER IORDACHE SD, DANEMAN N, AXELROD TS. 18. HAND (N Y). 2009 JUN;4(2):129-33. EPUB 2008 OCT 9. "MYCOBACTERIUM CHELONAE INFECTION FOLLOWING SILICONE ARTHROPLASTY OF THE METACARPOPHALANGEAL JOINTS: A CASE REPORT." (B)(4). UPPER LIMB SURGERY, (B)(6). "WE PRESENT A CASE OF INFECTION CAUSED BY AN UNCOMMON PATHOGEN, MYCOBACTERIUM CHELONAE, IN A PATIENT THAT UNDERWENT SWANSON SILICONE ARTHROPLASTY OF THE METACARPOPHALANGEAL JOINTS FOR RHEUMATOID ARTHRITIS. THIS IS THE FIRST REPORT OF AN INFECTION CAUSED BY NONTUBERCULOUS MYCOBACTERIA IN FLEXIBLE SILICONE IMPLANTS IN THE HAND. THE PATIENT WAS SUCCESSFULLY TREATED WITH IMPLANT REMOVAL, DEBRIDEMENT, AND ANTIMICROBIALS TAILORED TO THE RESULTS OF IN VITRO SUSCEPTIBILITY TESTING."

N

Patient 1

INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

N

Patient 1

CONCLUSION: NO DEVICE FAILURE. THE COMPLAINT WAS REVIEWED; HOWEVER, THE PRODUCT WAS NOT RETURNED. (B)(4).