MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® CEMENTLESS FEMORAL; HIP COMPONENT

Model Number 38PF-1052

Device Problem Material Disintegration (1177)

Patient Problems Pain (1994); Reaction (2414)

Event Date 02/10/2016

Event Type  Injury  

Event Description

Allegedly the patient was revised due to pain (right).Subject began feeling pain, post-surgery, this was first noted in medical records on (b)(6) 2016.Interarticular injection was given which reduced pain.Radiographs showed no signs of loosening/improper placement, but in surgery it was found that there was acetabular cup non integration with minor metallosis.Implant was removed and revised to a total hip.(b)(4).

• Brand Name: CONSERVE® A-CLASS® CEMENTLESS FEMORAL
• 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: 8169455
• MDR Text Key: 130500808
• Report Number: 3010536692-2018-01552
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38PF-1052
• Device Catalogue Number: 38PF-1052
• Device Lot Number: 1448512
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/07/2018
• Date Manufacturer Received: 12/07/2018
• 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
• Patient Age: 55 YR
• Patient Weight: 81