MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. PROFEMUR MODULAR FEMORAL NECK; HIP COMPONENT

Model Number	PHA01244
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to infection.Revision njr number: (b)(4).Side:l.Primary asa: p1 - fit and healthy.Mhra reference no: (b)(4).

• Brand Name: PROFEMUR MODULAR FEMORAL NECK
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10913683
• Report Number: 3010536692-2020-00717
• Device Sequence Number: 2885055
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012441
• UDI-Public: M684PHA012441
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/27/2020

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: Health Professional
• Device Model Number: PHA01244
• Device Catalogue Number: PHA01244
• Device Lot Number: 028559608
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 11/27/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention