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

Model Number	PHA01234
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly , the suspicion of adverse reaction to metal debris may be especially between neck and head.Dr.Wants to investigate the existence of adverse reaction to metal debris as following.Used our profemurxm, changeable neck, metal head only and used depuy pina cup and marason liner 28mm diameter flat.A few days ago, the patient complained of abnormal noise from his joint spinning prevention tab of 6 pin cup marathon liner 4 out of 6 damaged.Replace with marathon liner 32mm flat.Our steam is also replaced with a changeable neck ar8 long and a delta head 32 mm long.(b)(6).

• 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: 10361476
• Report Number: 3010536692-2020-00545
• Device Sequence Number: 16701446
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012341
• UDI-Public: M684PHA012341
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: Other
• Device Model Number: PHA01234
• Device Catalogue Number: PHA01234
• Device Lot Number: 1480653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 11/12/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 40 YR