MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD HIP COMPONENT

Model Number 38AM-4000

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Reaction (2414); Osteopenia/ Osteoporosis (2651)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to mom complications; pain; left pelvic discontinuity and severe pelvic bone lose. (left).

• Brand Name: CONSERVE® A-CLASS® BFH® 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: 8021466
• Report Number: 3010536692-2018-01389
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051348
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 38AM-4000
• Device Catalogue Number: 38AM-4000
• Device Lot Number: 078670401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/25/2018
• Event Location: No Information
• Date Manufacturer Received: 10/25/2018
• 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