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

Catalog Number PHA0-1204

Device Problems Detachment Of Device Component (1104); Device Slipped (1584); Metal Shedding Debris (1804)

Patient Problems Pain (1994); Limited Mobility Of The Implanted Joint (2671); Test Result (2695)

Event Date 04/03/2012

Event Type  Injury  

Event Description

Allegedly the patient was revised due to pain and decreased mobility; alleged patient's hip replacement system detached, disconnected, created metallic debris, and/or loosened from the patient's acetabulum.(left).

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01390, -01392.

Manufacturer Narrative

The complaint database was reviewed and analysis showed no trend for item/lot.

• 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: 4896961
• MDR Text Key: 21561172
• Report Number: 3010536692-2015-01391
• 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
• Report Date: 06/10/2015

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: PHA0-1204
• Device Lot Number: U0366703
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/03/2012
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/10/2015
• Initial Date FDA Received: 07/07/2015
• 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: 85 YR