MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT

Model Number 2600-0009

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 09/11/2018

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once investigation is complete.Trend will be evaluated.

Event Description

Allegedly, (b)(6) y/o male complaining of pain in the right hip, no trauma noted.Imaging found the ceramic liner had shattered, requiring immediate revision.During the case, original ceramic liner/shards and ceramic head were removed.Revised with lineage® a-class poly liner and a depuy ts biolox delta revision head.Unable to obtain defective liner to return to mpo.

• Brand Name: CERAMIC FEMORAL HEAD
• 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: 8032698
• MDR Text Key: 125934556
• Report Number: 3010536692-2018-01418
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/01/2018

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 Model Number: 2600-0009
• Device Catalogue Number: 2600-0009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/11/2018
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 11/02/2018
• Supplement Dates Manufacturer Received: 10/11/2018
• Supplement Dates FDA Received: 12/10/2018
• 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