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

Model Number	PHA01224
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/06/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, on (b)(6) 2020 the femoral neck of the device failed fracturing into two pieces, on that same date the device was surgically removed.During the revision procedure the doctor observed metallosis deep in the hip.(right hip).

• 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: 10800636
• Report Number: 3010536692-2020-00686
• Device Sequence Number: 19634461
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012241
• UDI-Public: M684PHA012241
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/06/2020

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: PHA01224
• Device Catalogue Number: PHA01224
• Device Lot Number: 117500324
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention