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

Catalog Number PHA0-1232

Device Problem Positioning Problem (3009)

Patient Problem Failure of Implant (1924)

Event Date 03/01/2014

Event Type  Injury  

Event Description

Allegedly, patient required revision following failure of hip replacement.The hip failed by rotating 90 degrees.

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be updated.This is the same event as 3010536692-2015-01400, -01401, -01402.

Manufacturer Narrative

Received additional information, updated sections.

Event Description

Additional information received (b)(6) 2015: allegedly patient was revised due to infection and cup loosening.

Manufacturer Narrative

Complaint database was reviewed and no trend for item/lot was identified.

• 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: 4903976
• MDR Text Key: 6067243
• Report Number: 3010536692-2015-01399
• 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,Followup
• Report Date: 06/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: PHA0-1232
• Device Lot Number: 0701185818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/16/2015
• 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: 63 YR