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

Model Number	38AM5235
Health Effect - Clinical Code	Metal Related Pathology (4530)
Date of Event	12/16/2018
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11381752
• Report Number: 3010536692-2021-00113
• Device Sequence Number: 4760086
• Product Code: JDL
• UDI-Device Identifier: 00192629060845
• UDI-Public: 192629060845
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

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