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

Model Number 38PF-1054

Device Problem Insufficient Information (3190)

Patient Problem Reaction (2414)

Event Date 12/13/2014

Event Type  Injury  

Event Description

Allegedly, patient revised due to pain and possible adverse reaction to metal debris.

Event Description

Allegedly, patient revised due to pain and possible adverse reaction to metal debris.

Event Description

Allegedly, patient revised due to pain and possible adverse reaction to metal debris.

• Brand Name: CONSERVE (R) A-CLASS (R) FEMORAL COMPONENT
• Type of Device: HIP IMPLANT
• 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: 7772559
• MDR Text Key: 116744434
• Report Number: 3010536692-2018-01024
• Device Sequence Number: 1
• Product Code: KXA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 38PF-1054
• Device Catalogue Number: 38PF-1054
• Device Lot Number: 1480376
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/12/2018
• Date Manufacturer Received: 07/12/2018
• 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 Weight: 100