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

Catalog Number PHA0-1232

Device Problems Material Discolored (1170); Difficult to Remove (1528); Material Integrity Problem (2978)

Patient Problem Unspecified Infection (1930)

Event Date 02/04/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly surgeon found an infection several years after initial revision.Observation during revision surgery: difficult to remove the neck from the stem, the stem taper portion of the neck is black and indent on the taper of stem side.

Manufacturer Narrative

This is the same event as 3010536692-2015-00631, -00632, -00633, -00635.This report will be updated when investigation is complete.Trends will be evaluated.This event occurred in (b)(6).

• 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 ; 901867-441
• MDR Report Key: 4652572
• MDR Text Key: 13502290
• Report Number: 3010536692-2015-00634
• Device Sequence Number: 1
• Product Code: LWJ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2015

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: PHA0-1232
• Device Lot Number: 0511365247
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/04/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/05/2015
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR