WRIGHT-MEDICAL * 428-3004

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-05-22 for WRIGHT-MEDICAL * 428-3004 manufactured by Wright Medical Tech.

Event Text Entries

[268974] The problem in one of a possible implant pt reaction. In summary, a convex condylar titanium implant for thumb suprametacarpal osteoarthritis was implanted. Pt did well post-operatively but within 6 months was having recurring pain. This pain progressed and x-ray started to show lucency around the implant. It finally had to be removed because of persistent pain but was thought to be done to implant loosening. At re-operation, significant inflammatory debris and tissue was seen with metallic debris as well.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 398154
• MDR Report Key: 398154
• Date Received: 2002-05-22
• Date of Report: 2001-12-13
• Date of Event: 2001-09-10
• Date Facility Aware: 2001-09-10
• Report Date: 2001-12-13
• Date Added to Maude: 2002-06-10
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WRIGHT-MEDICAL
• Generic Name: TITANIUM BASAL THUMB IMPLANT
• Product Code: KWE
• Date Received: 2002-05-22
• Returned To Mfg: 2001-10-01
• Model Number: *
• Catalog Number: 428-3004
• Lot Number: 027A049935
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: R
• Device Age: *
• Implant Flag: Y
• Date Removed: V
• Device Sequence No: 1
• Device Event Key: 387205
• Manufacturer: WRIGHT MEDICAL TECH
• Manufacturer Address: 5677 AIRLINE ROAD ARLINGTON TN 38002 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2002-05-22