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U.S. Department of Health and Human Services

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

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WRIGHT MEDICAL TECHNOLOGY, INC. SWANSON FINGER JOINT PROSTHESIS, FINGER, POLYMER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Ossification (1428)
Event Type  Injury  
Manufacturer Narrative

Literature citation: daecke et al. A prospective, randomized comparison of 3 types of proximal interphalangeal joint arthroplasty. Jhs. 2012; 37a: 1170-1779. 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 a 2012 literature article, by chung et al. Titled a prospective, randomized comparison of 3 types of proximal interphalangeal joint arthroplasty, the authors describe 2 revisions of swanson pip joint arthroplasties, as well as a 33% incidence of heterotopic ossification.

 
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Brand NameSWANSON FINGER JOINT
Type of DevicePROSTHESIS, 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 Key8199063
MDR Text Key131485730
Report Number1043534-2018-00202
Device Sequence Number1
Product Code KWF
Combination Product (Y/N)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 12/04/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 12/27/2018 Patient Sequence Number: 1
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