MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE FEMORAL RESURFACING HEAD 46MM; HIP COMPONENT

Model Number 38031046

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to infection.Revision njr number: 4432449.Side: r.Primary asa: p2 - mild disease not incapacitating.

• Brand Name: CONSERVE FEMORAL RESURFACING HEAD 46MM
• Type of Device: 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: 10339187
• MDR Text Key: 202740813
• Report Number: 3010536692-2020-00519
• Device Sequence Number: 1
• Product Code: KXA
• UDI-Device Identifier: M684380310461
• UDI-Public: M684380310461
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K944752
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/29/2020

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
• Device Operator: Health Professional
• Device Model Number: 38031046
• Device Catalogue Number: 38031046
• Device Lot Number: 115283555
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/15/2020
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/29/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention