MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE CEMENTLESS FEMORAL COMPONENT 52MM; HIP COMPONENT

Model Number	38PF1052
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	08/08/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
Sae # (b)(4).Allegedly, the patient had a small stumble.Imaging showed a right neck of femur fracture.All components were revised.

• Brand Name: CONSERVE CEMENTLESS FEMORAL COMPONENT 52MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11739633
• Report Number: 3010536692-2021-00260
• Device Sequence Number: 3091821
• Product Code: JDI
• UDI-Device Identifier: M68438PF10521
• UDI-Public: M68438PF10521
• 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: 2015
• Device Explanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/28/2021

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: 38PF1052
• Device Catalogue Number: 38PF1052
• Device Lot Number: 1575658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/16/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 04/28/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 97