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

Model Number	PHA01204
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation completed.Evaluation codes added.
Event or Problem Description
Allegedly, the patient's acetabular components were revised on (b)(6) 2008 due to rotational instability, and a hematoma was found and removed during the operation (incident group #(b)(4)).On (b)(6) 2017, the patient experienced a modular neck fracture.All components were removed during this revision on (b)(6) 2017.

• 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: 10502720
• Report Number: 3010536692-2020-00607
• Device Sequence Number: 11552195
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012041
• UDI-Public: M684PHA012041
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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: PHA01204
• Device Catalogue Number: PHA01204
• Device Lot Number: 018525557
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/19/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 118