MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® PLUS CUP; HIP COMPONENT

Model Number 38024652

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Allegedly, the head and the neck on the left side were revised due to pain.Non explanted products: product id: prlx5812 profemur® lx stem sz 12 5/8 ps coated/ lot number: 0711374029/ qty: 1 product id: 38024652 conserve® thin shell 46mm id 52mm od beaded/ lot number: 0611361525/ qty: 1.

• Brand Name: CONSERVE® PLUS CUP
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18393733
• MDR Text Key: 331323340
• Report Number: 3010536692-2023-00235
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2023

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: 38024652
• Device Catalogue Number: 38024652
• Device Lot Number: 0611361525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female