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U.S. Department of Health and Human Services

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

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WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON; PROSTHESIS, FINGER, POLYMER Back to Search Results
Device Problem Break (1069)
Patient Problem Pain (1994)
Event Type  Injury  
Manufacturer Narrative
Literature citation: goldfarb et al.Metacarpophalangeal joint arthroplasty in rheumatoid arthritis.The journal of bone and joint surgery.2003; 85-a : page(s) 1869-1878.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 goldfarb et al.Titled "metacarpophalangeal joint arthroplasty in rheumatoid arthritis" it was reported that an investigation was performed to evaluate long term outcomes of patients.Thirty-seven hands were treated with a total of 148 swanson implants: eighty-four hp swanson implants were used (prior to 1986), and sixty-four hp-100 swanson implants were implanted.Of the 148 swanson implants, ninety-nine (67%) were broken, twenty-five (17%) were severely deformed, and twenty-four (16%) were intact.Forty-nine (58%) of the eighty-four hp swanson silicone implants (used prior to 1986) were fractured at an average of seventeen years after the surgery, and fifty (78%) of the sixty-four hp-100 swanson implants were fractured at an average of 12.7 years.The patients were satisfied or very satisfied with the function of 38% (twenty) of the fifty-two hands, and they reported no pain in 27% (fourteen) of the fifty-two hands.There was pain, ranging from occasional to constant, in the other thirty-eight hands.The ability to perform activities of daily living, work capacity, satisfaction with the cosmetic appearance, and overall satisfaction varied considerably among the patients.
 
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Brand Name
SWANSON
Type of Device
PROSTHESIS, FINGER, 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 Key8160239
MDR Text Key130212889
Report Number1043534-2018-00192
Device Sequence Number1
Product Code KWF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Physician
Type of Report Initial
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2018
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
Was the Report Sent to FDA? No
Event Location Home
Date Manufacturer Received11/16/2018
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) Required Intervention;
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