MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE(R) STATURE FEMUR; KNEE COMPONENT

Catalog Number KFTC-NN3L

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arthritis (1723); Muscular Rigidity (1968); Pain (1994); Loss of Range of Motion (2032)

Event Date 05/01/2014

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly the patient was revise due to pain; stiffness; progressive arthritis (left).Revision njr index no: (b)(4).

Manufacturer Narrative

This is the same event as 3010536692-2015-00311, -00312.This report will be updated when investigation is complete.Trends will be evaluated.This event occurred in (b)(6).

• Brand Name: ADVANCE(R) STATURE FEMUR
• Type of Device: KNEE 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 ; 901867-441
• MDR Report Key: 4489893
• MDR Text Key: 13168944
• Report Number: 3010536692-2015-00310
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: KFTC-NN3L
• Device Lot Number: 1413452
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/01/2014
• Event Location: Hospital
• Date Manufacturer Received: 03/30/2015
• 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