MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 44MM; HIP COMPONENT

Model Number	38031044
Health Effect - Clinical Code	Osteolysis (2377)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient was revised due to aseptic loosening socket; lysis socket.Revision njr number: (b)(6).Side: r.Primary asa: p2 - mild disease not incapacitating.(b)(4).

• Brand Name: CONSERVE FEMORAL RESURFACING HEAD 44MM
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11100371
• Report Number: 3010536692-2020-00798
• Device Sequence Number: 10968452
• Product Code: KXA
• UDI-Device Identifier: M684380310441
• UDI-Public: M684380310441
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K944752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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: 38031044
• Device Catalogue Number: 38031044
• Device Lot Number: 058570375
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2020
• Initial Report FDA Received Date: 12/31/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention