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

Model Number	PHA01214
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly the patient was experiencing unknown mom complications.Additional information received from legal on (b)(6) 2019 : updating reason for revision and adding implant date , explant date , hospital name , doctor name , products and lot numbers.Allegedly, patient was revised due to adverse tissue reaction to metal debris, corrosion and resultant metal ions.

• 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: 10402866
• Report Number: 3010536692-2020-00576
• Device Sequence Number: 2975545
• Product Code: LWJ
• UDI-Device Identifier: M684PHA012141
• UDI-Public: M684PHA012141
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2005
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2020

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: PHA01214
• Device Catalogue Number: PHA01214
• Device Lot Number: U0370550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2019
• Initial Report FDA Received Date: 08/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention