MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT

Model Number 38AM-4204

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Type  Injury  

Event Description

Allegedly, patient suffering from mom complications. (left) additional information received from litigation on 01/08/2019. Allegedly the patient was revised due to mom complications. Updated the implant date from (b)(6) 2006 to (b)(6) 2006 and added the revision date.

• Brand Name: CONSERVE(R) TOTAL A-CLASS HEAD
• 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: 8305952
• Report Number: 3010536692-2019-00306
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: 38AM-4204
• Device Catalogue Number: 38AM-4204
• Device Lot Number: 085261226
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/08/2019
• Event Location: No Information
• Date Manufacturer Received: 01/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

• Patient Outcome(s): Required Intervention