FDA.reportPublic FDA data

MAUDE MDR 8200507

MDR report key
8200507
Report number
1043534-2018-00211
Event key
0
Event type
3
Date received
2018-12-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR MATTHEW PARRISH
Address
1023 CHERRY RD MEMPHIS TN 38117 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SWANSON FINGER JOINTPROSTHESIS, FINGER, POLYMERWRIGHT MEDICAL TECHNOLOGY, INC.KWFUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-2701. R

Event Narratives#

N

Patient 1

LITERATURE CITATION: JENSEN ET AL. SILASTIC ARTHROPLASTY IN RHEUMATOID MCP-JOINTS. ADA ORTHOP SCAND. 1986; 57: 138-140 NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

D

Patient 1

ALLEGEDLY, IN A 1986 LITERATURE ARTICLE, BY SWANSON ET AL. TITLED FLEXIBLE IMPLANT ARTHROPLASTY IN THE PROXIMAL INTERPHALANGEAL JOINT OF THE HAND, THE AUTHORS REPORT 4 IMPLANT FRACTURES IN SITU FOLLOWING MCP JOINT ARTHROPLASTY WITH SWANSON FINGER JOINT IMPLANTS.