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

Catalog Number PHA0-12XX

Device Problem Metal Shedding Debris (1804)

Patient Problems Unspecified Infection (1930); Inflammation (1932); Pain (1994); Thrombus (2101); Discomfort (2330); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

Allegedly, patient suffering from pain, discomfort, dysfunction, metallosis, dvt, inflammation, infection and septic hip.(left).

Manufacturer Narrative

This is the same event as 3010536692-2014-01528, -01529.This report will be updated when investigation is completed.

• 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: 4199091
• MDR Text Key: 5037587
• Report Number: 3010536692-2014-01530
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/01/2014

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?: No
• Device Operator: Other
• Device Catalogue Number: PHA0-12XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/09/2014
• Initial Date FDA Received: 10/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other