MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) PLUS SUPER FINISH FEMORAL; HIP COMPONENT

Model Number 3802-1046

Device Problem Insufficient Information (3190)

Patient Problem Pain (1994)

Event Date 11/21/2017

Event Type  Injury  

Event Description

The patient was suffering from hip pain.Prof davis decided to revise the conserve cup, conserve bfh femoral head, and neck.The profemur l stem was left in situ.A new vv8 short modular neck and 36mm +0mm biolox delta head was implanted along with a s&n r3 cup with poly liner.Prof davis stated that the pain was caused by wear, caused by subluxation & edge loading.

• Brand Name: CONSERVE(R) PLUS 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: 7063256
• MDR Text Key: 93073885
• Report Number: 3010536692-2017-01488
• Device Sequence Number: 1
• Product Code: NXT
• Combination Product (y/n): N
• Reporter Country Code: GB
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 3802-1046
• Device Catalogue Number: 3802-1046
• Device Lot Number: 04335653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 11/21/2017
• Date Manufacturer Received: 11/21/2017
• 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: 62 YR
• Patient Weight: 66