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

Catalog Number PHA0-1254

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Pain (1994); Skin Discoloration (2074); Swelling (2091); Toxicity (2333); Ambulation Difficulties (2544); Fluid Discharge (2686)

Event Date 12/30/2014

Event Type  Injury  

Event Description

Allegedly, pt experienced pain and ambulatory difficulty; tested positive for elevated cocr levels.During the right hip revision, a large pseudotumor with dark coloration and a large amount of cloudy fluid was identified; post-operative leg-length discrepancy.

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01042, -01043, -01045.

Manufacturer Narrative

Please disregard this report.There was no complaint stated against the device.

• 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 ; 9018674771
• MDR Report Key: 4791641
• MDR Text Key: 5800215
• Report Number: 3010536692-2015-01044
• 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,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

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: PHA0-1254
• Device Lot Number: 056345330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/30/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/27/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/14/2015
• 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: 64 YR