MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE CEMENTLESS FEMORAL COMPONENT 48MM; HIP COMPONENT

Model Number	38PF1048
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	03/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
Event or Problem Description
Allegedly, xray showed a fractured at the femoral neck of his right side , just below the level of prosthesis.A visit with dr (b)(6) on (b)(6) 2019 indicated the stress fractured was healed , and subject was gradually returning to regular activities.Subject was treated non-operatively and received tylenol and tramadol while in the emergency department.
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.

• Brand Name: CONSERVE CEMENTLESS FEMORAL COMPONENT 48MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10320084
• Report Number: 3010536692-2020-00500
• Device Sequence Number: 14219232
• Product Code: KXA
• UDI-Device Identifier: M68438PF10481
• UDI-Public: M68438PF10481
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K082673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2020

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: Other
• Device Model Number: 38PF1048
• Device Catalogue Number: 38PF1048
• Device Lot Number: 1675586
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 07/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 60 YR
• Patient Weight: 72