MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) Z STEM PLASMA SPRAYED; HIP COMPONENT

Catalog Number PHA0-0266

Device Problem Delamination (2904)

Patient Problem Reaction (2414)

Event Date 01/07/2014

Event Type  Injury  

Event Description

Allegedly revised due to "fluid, metallosis, and flaking of the stem into the bone causing wear on the ball and socket." patient's husband stated "fluid caused deterioration of the bone".

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 3010536692-2014-00491, 00492, 00493.

• Brand Name: PROFEMUR(R) Z STEM PLASMA SPRAYED
• 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: 3685938
• MDR Text Key: 20266756
• Report Number: 3010536692-2014-00494
• Device Sequence Number: 1
• Product Code: LPH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

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: PHA0-0266
• Device Lot Number: 086371758
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/07/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 03/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/21/2014
• 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