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

Model Number	PHA01254
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	04/17/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, during the squat the patient felt a strong pain in the left hip.The patient was revised due to broken neck.

• 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: 10514838
• Report Number: 3010536692-2020-00618
• Device Sequence Number: 1178921
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012541
• UDI-Public: M684PHA012541
• Combination Product (Y/N): N
• Initial Reporter Country: SI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2020

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: PHA01254
• Device Catalogue Number: PHA01254
• Device Lot Number: 078580871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/09/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 09/10/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention