MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME; HIP COMPONENT

Model Number PHAC1252

Device Problems Material Disintegration (1177); Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

Allegedly, pain slightly elevated metal ion levels, gilliland removed the neck, head and dual mobility liner.He replaced the vv8 neck, biolox 28mm head with a short ti straight neck and biolox 28mm long.

Manufacturer Narrative

Upon investigation it was found no alleged mom complications.

• Brand Name: PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9203750
• MDR Text Key: 162971717
• Report Number: 3010536692-2019-01102
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684PHAC12521
• UDI-Public: M684PHAC12521
• Combination Product (y/n): N
• PMA/PMN Number: K091423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: PHAC1252
• Device Catalogue Number: PHAC1252
• Device Lot Number: 1641146
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/18/2019
• Date Manufacturer Received: 09/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention