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

Catalog Number PHA0-1202

Device Problem Malposition of Device (2616)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This investigation is not complete.The trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 3010536692-2016-00344 and 00346.This event occurred in (b)(6).

Event Description

Allegedly the patient was experiencing persistent groin pain.There was possible psoas muscle inflammation and acetabular impingement.The shell was revised due to alleged proud cup and psoas tendon irritation.Revision with zimmer cup and phac-1204 neck and 2600-0026 head.The implant did not fail but it is alleged that the positioning may have been unsatisfactory (proud).

• 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: 5486746
• MDR Text Key: 39895129
• Report Number: 3010536692-2016-00345
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K003016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/18/2016

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: 1510309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/18/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/05/2016
• Date Device Manufactured: 08/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR