MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PERFECTA(R) II FEMORAL STEM; HIP COMPONENT

Catalog Number 38XX-XXXX

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Reaction (2414)

Event Type  Injury  

Manufacturer Narrative

This report will be updated when investigation is complete.Trends will be evaluated.

Event Description

Allegedly, per paper by somers et al., "high serum ion levels in conserve plus big femoral head cemented total hip arthroplasty.", hip int.2016 sep.: allegedly hip revised 2 years post-primary tha for a secondary infection of a large adverse local tissue reaction.A large cystic pseudotumor extending into the abdominal cavity along the psoas muscle.Cup angle normal at 43 deg.Serum cobalt level was 21.0 microgram/liter.All components revised in two stage revision.

• Brand Name: PERFECTA(R) II FEMORAL STEM
• 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: 5999547
• MDR Text Key: 56454480
• Report Number: 3010536692-2016-01242
• Device Sequence Number: 1
• Product Code: HWT
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 38XX-XXXX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/26/2016
• Date Manufacturer Received: 09/26/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention