MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY, INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT, CODE:LWJ

Catalog Number PHA0-1232

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seroma (2069)

Event Date 05/14/2013

Event Type  Injury  

Event Description

Allegedly, primary surgery was performed at (b)(6) 2010.After the surgery, the surgeon found like pseudotumor by mri when the patient received the routine medical checkup.So revision surgery was performed at (b)(6) 2013.As the observation of diseased site, there was no any tissue like pseudotumor.Medium activity level.

Manufacturer Narrative

The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2014-00054, 00056, 00060.This event occurred in (b)(6).

Manufacturer Narrative

Complaint review was conducted and analysis showed no trend for item/lot.

• Brand Name: PROFEMUR(R) MODULAR FEMORAL NECK
• 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: 3557819
• MDR Text Key: 4214440
• Report Number: 1043534-2014-00055
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/25/2013

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: PHA0-1232
• Device Lot Number: 0501128452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/14/2013
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 01/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR