MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) MODULAR FEMORAL NECK; HIP COMPONENT

Catalog Number PHA0-1202

Device Problem Corroded (1131)

Patient Problems Pain (1994); Seroma (2069); Reaction (2414)

Event Date 07/29/2014

Event Type  Injury  

Manufacturer Narrative

The complaint database was reviewed and analysis showed no trend for item/lot.

Event Description

Allegedly the pt felt pain in her hip in (b)(6) 2013.The surgeon found a pseudotumor by x-ray.During the revision surgery, her hip had some tela which had no blood.Each junction had black materials.The stem-neck junction was blacker than the head-neck junction.The surgeon has never seen this before.The surgeon wants to know the condition for each articulation surfaces and the condition for both junctions.The surgeon especially wants us to investigate the condition for the distal neck taper.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 event occurred in (b)(6).This is the same event as 3010536692-2014-01200, 01201.

• Brand Name: PROFEMUR(R) MODULAR FEMORAL NECK
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 901867-441
• MDR Report Key: 4033922
• MDR Text Key: 12576759
• Report Number: 3010536692-2014-01199
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/13/2014

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?: Yes
• Device Operator: Other
• Device Catalogue Number: PHA0-1202
• Device Lot Number: 0801189724
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/29/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/20/2014
• Initial Date FDA Received: 08/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/25/2014
• 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