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

Model Number 38025056

Device Problems Failure to Osseointegrate (1863); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, cup appears to be incorrectly positioned.Head was removed along with shell and came out with the neck extraction device.Appears that there was a little ingrowth on the cup and stem.(right hip) photos of explants and x ray are being sent.

• Brand Name: CONSERVE PLUS CUP
• 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: 10828634
• MDR Text Key: 215889564
• Report Number: 3010536692-2020-00695
• 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: Physician
• Type of Report: Initial
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38025056
• Device Catalogue Number: 38025056
• Device Lot Number: 037410508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2020
• Date Manufacturer Received: 10/26/2020
• 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