SWANSON UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,l report with the FDA on 2019-03-04 for SWANSON UNK manufactured by Wright Medical Technology, Inc..

Event Text Entries

[137750567] Literature citation: ter keurs et al. First metatarsophalangeal joint replacement: long-term results of a double stemmed flexible silicone prosthesis. Foot and ankle surgery. 2011; 17: 224-227. Neither the device nor applicable imaging films were returned to the manufacturer for evaluation, therefore, the cause of the event cannot be determined.
Patient Sequence No: 1, Text Type: N, H10


[137750568] Allegedly, in an article by ter keurs et al, titled "first metatarsophalangeal joint replacement: long-term results of a double stemmed flexible silicone prosthesis" the authors report the removal of 3 devices due to infection, 9 cases of radiolucency, 20 cases of bone resorption, and 41 cases of sclerosis.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1043534-2019-00020
MDR Report Key8388234
Report SourceFOREIGN,HEALTH PROFESSIONAL,L
Date Received2019-03-04
Date of Report2019-02-03
Date of Event2009-10-11
Date Mfgr Received2019-02-03
Date Added to Maude2019-03-04
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR MATTHEW PARRISH
Manufacturer Street1023 CHERRY RD
Manufacturer CityMEMPHIS TN 38117
Manufacturer CountryUS
Manufacturer Postal38117
Manufacturer G1WRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Street11576 MEMPHIS ARLINGTON RD
Manufacturer CityARLINGTON TN 38002
Manufacturer CountryUS
Manufacturer Postal Code38002
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSWANSON
Generic NamePROSTHESIS, TOE, CONSTRAINED, POLYMER
Product CodeKWH
Date Received2019-03-04
Model NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerWRIGHT MEDICAL TECHNOLOGY, INC.
Manufacturer Address11576 MEMPHIS ARLINGTON RD ARLINGTON TN 38002 US 38002


Patients

Patient NumberTreatmentOutcomeDate
101. Congenital Not Applicablenomaly; 2. Required No Informationntervention 2019-03-04

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