FDA.reportPublic FDA data

MAUDE MDR 8210526

MDR report key
8210526
Report number
1043534-2019-00002
Event key
0
Event type
3
Date received
2019-01-02
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
12019-01-0201. R

Event Narratives#

N

Patient 1

LITERATURE CITATION: TAKIGAWA ET AL. LONG-TERM ASSESSMENT OF SWANSON IMPLANT ARTHROPLASTY IN THE PROXIMAL INTERPHALANGEAL JOINT OF THE HAND. THE JOURNAL OF HAND SURGERY.2004; 29A: 785-795. 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 2004 LITERATURE ARTICLE, BY TAKIGAWA ET AL. TITLED SEVENTEEN-YEAR SURVIVORSHIP ANALYSIS OF SILASTIC METACARPOPHALANGEAL JOINT REPLACEMENT, THE AUTHORS REPORT 11 IMPLANT FRACTURES AND 11 REVISIONS FOLLOWING MCP JOINT ARTHROPLASTY WITH SWANSON FINGER JOINT IMPLANTS.