MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. GUARDIAN® RESURFACING FEMUR AXIAL PIN; HIP COMPONENT

Model Number	2500-2112
Medical Device Problem Code	Unstable (1667)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This complaint will be updated once investigation is complete.Trends will be evaluated.This report is being submitted retrospectively per fda request.
Event or Problem Description
Allegedly the patient was revised due to instability.

• Brand Name: GUARDIAN® RESURFACING FEMUR AXIAL PIN
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 8162058
• Report Number: 3010536692-2018-00890
• Device Sequence Number: 17831842
• Product Code: JDI
• UDI-Device Identifier: M684250021121
• UDI-Public: M684250021121
• 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: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2018

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: 2500-2112
• Device Catalogue Number: 2500-2112
• Device Lot Number: 02470143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 12/13/2018
• Supplement Report FDA Received Date: 12/13/2018
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female