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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON; PROSTHESIS, TOE, CONSTRAINED, POLYMER

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WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON; PROSTHESIS, TOE, CONSTRAINED, POLYMER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Event Date 10/11/2009
Event Type  Injury  
Manufacturer Narrative
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.
 
Event Description
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.
 
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Brand Name
SWANSON
Type of Device
PROSTHESIS, TOE, CONSTRAINED, POLYMER
Manufacturer (Section D)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer (Section G)
WRIGHT MEDICAL TECHNOLOGY, INC.
11576 memphis arlington rd
arlington TN 38002
Manufacturer Contact
matthew parrish
1023 cherry rd
memphis, TN 38117
MDR Report Key8388234
MDR Text Key137750567
Report Number1043534-2019-00020
Device Sequence Number1
Product Code KWH
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K780132
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation Physician
Type of Report Initial
Report Date 02/03/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Event Location Other
Initial Date Manufacturer Received 02/03/2019
Initial Date FDA Received03/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Congenital Anomaly; Required Intervention;
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