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

Model Number 38NS0N35

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient was revised due to pain and infection.Components not revised: dynasty® bf shell primary 58mm group g product id: dbfpgg58 lot number: 1817132 profemur® preserve classic size 9 varus 8dg hip stem product id: pprcle09 lot number: 1793809.

• 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
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 11849000
• MDR Text Key: 251655247
• Report Number: 3010536692-2021-00307
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: M68438NS0N351
• UDI-Public: M68438NS0N351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072656
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• 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: 1781735
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/27/2021
• Date Manufacturer Received: 04/27/2021
• 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