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

Model Number SIZE 4 (2EA)

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/19/2015

Event Type  malfunction  

Event Description

Pre-op diagnosis: rheumatoid arthritis.Procedure(s): hand procedure - right re-do metacarpophalangeal joints (mcpj), silastic metacarpophalangeal joint arthroplasty (smpa) digits 2-5.Post-op diagnosis: same.

• Brand Name: JOINT, FINGER SWANSON
• Type of Device: PROSTHESIS, FINGER, POLYMER
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 1023 cherry road; memphis TN 38117
• MDR Report Key: 5396001
• MDR Text Key: 36984568
• Report Number: 5396001
• Device Sequence Number: 1
• Product Code: MPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: SIZE 4 (2EA)
• Device Catalogue Number: G4700004
• Device Lot Number: 047431996
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2015
• Event Location: Hospital
• Date Report to Manufacturer: 11/18/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR