MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR(R) Z STEM PLASMA SPRAYED; HIP COMPONENT

Catalog Number PHA0-0266

Device Problem Insufficient Information (3190)

Patient Problems Cellulitis (1768); Unspecified Infection (1930); Pain (1994); Sepsis (2067); Complaint, Ill-Defined (2331); Patient Problem/Medical Problem (2688)

Event Date 03/22/2014

Event Type  Injury  

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.This is the same event as 3010536692-2015-01776, -01777, -01786.

Event Description

Allegedly, patient was revised due to mom complications: pain and ramps; infectious disease; joint septic arthritis; pneumococcal septicemia; abdominal wall cellulitis; sepsis due to pneumococcal bacteremia: left.

Manufacturer Narrative

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

• Brand Name: PROFEMUR(R) Z STEM PLASMA SPRAYED
• 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: 5114657
• MDR Text Key: 27159830
• Report Number: 3010536692-2015-01787
• Device Sequence Number: 1
• Product Code: LPH
• 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
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/24/2015

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: PHA0-0266
• Device Lot Number: 067442305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/22/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/30/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 47 YR