MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL FEMORAL HEAD; HIP COMPONENT

Device Problem Material Disintegration (1177)

Patient Problems Collapse (2416); Cusp Tear (2656)

Event Type  Injury  

Event Description

Allegedly the patient was revised due to the following mom complications: toxic levels of cobalt and chromium debris; tissue and bone destruction.

• Brand Name: CONSERVE® TOTAL FEMORAL 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: 8754015
• MDR Text Key: 149817293
• Report Number: 3010536692-2019-00878
• Device Sequence Number: 1
• Product Code: LZO
• 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: 07/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/24/2019
• Date Manufacturer Received: 06/24/2019
• 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