MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® COCR NECK; HIP COMPONENT

Model Number PHAC-1252

Device Problem Corroded (1131)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This complaint will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly the patient was revised due to metallosis.Dr.(b)(6) considered the corrosion on the neck/stem junction indicates a complete removal of the stem.The cup was well positioned so she put in a zbo stem and head and replaced the liner.The following component have no alleged deficiency and were not revised during this surgery: dynasty® bf shell primary, dbfpgg58, lot # 1657019, qty.1.

• Brand Name: PROFEMUR® COCR 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 ; 9018674771
• MDR Report Key: 8196398
• MDR Text Key: 131405202
• Report Number: 3010536692-2018-01561
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHAC-1252
• Device Catalogue Number: PHAC-1252
• Device Lot Number: 1656757
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/04/2018
• Date Manufacturer Received: 12/07/2018
• 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