MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® SUPER FINISH FEMORAL; HIP COMPONENT

Model Number 3803-1040

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to pain; adverse soft tissue reaction to particle debris.Revision njr number: (b)(4).Side: l.Primary asa: p1 - fit and healthy.

• Brand Name: CONSERVE® SUPER FINISH 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: 7551100
• MDR Text Key: 109480381
• Report Number: 3010536692-2018-00731
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

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: Physician
• Device Model Number: 3803-1040
• Device Catalogue Number: 3803-1040
• Device Lot Number: 0748991510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/15/2018
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 05/29/2018
• 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: 41 YR