MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL A-CLASS® 54MM FEMORAL HEAD; HIP COMPONENT

Model Number	38AC5400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Reaction (2414)
Type of Reportable Event	Malfunction
Event or Problem Description
Metal on metal head, sleeve and neck were removed and were replaced with our 28 l ceramic head, long straight neck and strikers dual mobility.

• Brand Name: CONSERVE® TOTAL A-CLASS® 54MM FEMORAL HEAD
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9705998
• Report Number: 3010536692-2019-01025
• Device Sequence Number: 11598611
• Product Code: JDL
• UDI-Device Identifier: M68438AC54001
• UDI-Public: M68438AC54001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K051348
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/13/2020

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: 38AC5400
• Device Catalogue Number: 38AC5400
• Device Lot Number: 069861564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2019
• Initial Report FDA Received Date: 02/13/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR