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

Catalog Number PHA0-12XX

Device Problems Break (1069); Device Slipped (1584); Noise, Audible (3273)

Patient Problems Pain (1994); Ambulation Difficulties (2544)

Event Date 06/12/2013

Event Type  Injury  

Event Description

Allegedly patient experienced complications: audible noises, pain, gait, mobility issues, acetabular cup has loosened, and broken screws.

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01099, -01101, -01102, -01103.This event occurred in (b)(6).

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 ; 901867-477
• MDR Report Key: 4798039
• MDR Text Key: 5833646
• Report Number: 3010536692-2015-01100
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: PHA0-12XX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 06/12/2013
• Event Location: Hospital
• Date Manufacturer Received: 07/13/2015
• 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