MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR(R) ROUGHENED DISTAL STEM, TAPERED; HIP COMPONENT, CODE:LWJ

Catalog Number PPW3-8005

Device Problem Insufficient Information (3190)

Patient Problems Failure to Anastomose (1028); Reaction (2414)

Event Date 04/15/2013

Event Type  Injury  

Event Description

Allegedly the patient experienced pain and mom soft tissue reaction.

Manufacturer Narrative

Investigation is not complete.Event code is addressed in package insert.Trends will be evaluated.This is the same event as 1043534-2014-00083, -00084, -00085.This report will be updated when investigation is completed.This event occurred in the (b)(6).

• Brand Name: PROFEMUR(R) ROUGHENED DISTAL STEM, TAPERED
• Type of Device: HIP COMPONENT, CODE:LWJ
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY, INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 901867-414
• MDR Report Key: 3564765
• MDR Text Key: 4216225
• Report Number: 1043534-2014-00086
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/13/2013

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?: No
• Device Operator: Other
• Device Catalogue Number: PPW3-8005
• Device Lot Number: S11118428
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/15/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/02/2014
• Initial Date FDA Received: 01/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR