MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE TOTAL A-CLASS HEAD; HIP COMPONENT

Model Number 38AM5235

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Metal Related Pathology (4530)

Event Date 12/16/2018

Event Type  Injury  

Event Description

Allegedly the patient was revised due to titanium modular neck fracture.Additional information received on 02/18/2021: new revision surgery findings, adding date of incident.Allegedly, the patient had pseudotumor secondary to metal reaction.

• Brand Name: CONSERVE TOTAL A-CLASS 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: 11381752
• MDR Text Key: 233716603
• Report Number: 3010536692-2021-00113
• Device Sequence Number: 1
• Product Code: JDL
• UDI-Device Identifier: 00192629060845
• UDI-Public: 192629060845
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AM5235
• Device Catalogue Number: 38AM5235
• Device Lot Number: 128752859
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/18/2021
• Date Manufacturer Received: 02/18/2021
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention