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

Model Number 38AM-460X

Device Problem Loose or Intermittent Connection (1371)

Patient Problems Pain (1994); Reaction (2414)

Event Date 10/05/2010

Event Type  Injury  

Event Description

Orig.Surg.(b)(6) 2007, (b)(6), moderate activity level.Allegedly the cup was loose.Revised due to hip pain.Additional information received 05/09/2018 from wright medical litigation.Implant and explant dates.

• 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: 7551086
• MDR Text Key: 109480372
• Report Number: 3010536692-2018-00727
• 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: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 38AM-460X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2010
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 05/09/2018
• Date Manufacturer Received: 05/09/2018
• 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