MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL SHORT NECK SLEEVE ADDED CLEARANCE; HIP COMPONENT

Model Number 38NS0N35

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, for unknown reasons patient received a revision.

Manufacturer Narrative

An update was made to this event on (b)(6) 2020 after the investigation review: allegedly, the patient was revised due to the fracture of the modular neck.Therefore the there is no alleged deficiency against this product.Please void the initial report.

• Brand Name: CONSERVE TOTAL SHORT NECK SLEEVE ADDED CLEARANCE
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9847344
• MDR Text Key: 183878197
• Report Number: 3010536692-2020-00254
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: M68438NS0N351
• UDI-Public: M68438NS0N351
• Combination Product (y/n): N
• PMA/PMN Number: K072656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38NS0N35
• Device Catalogue Number: 38NS0N35
• Device Lot Number: 1428317
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/27/2020
• Date Manufacturer Received: 02/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention