MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE A-CLASS BFH HEAD LONG NECK 40MM; HIP COMPONENT

Model Number 38AM4035

Device Problem Material Disintegration (1177)

Patient Problem No Information (3190)

Event Date 08/29/2018

Event Type  Injury  

Event Description

Allegedly, the x-ray showed dislocation of the acetabular liner with superior migration of the femoral head into the acetabulum.The physician found large loose poly fragment floating within the hip capsule as well as severe metallosis.Total hip components were removed.

• Brand Name: CONSERVE A-CLASS BFH HEAD LONG NECK 40MM
• 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: 10443385
• MDR Text Key: 204049826
• Report Number: 3010536692-2020-00589
• Device Sequence Number: 1
• Product Code: KWA
• UDI-Device Identifier: M68438AM40351
• UDI-Public: M68438AM40351
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021349
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38AM4035
• Device Catalogue Number: 38AM4035
• Device Lot Number: 1412848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2020
• Date Manufacturer Received: 08/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention