MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY 15DEG CROSS-LINKED POLYETHYLENE LINER; HIP COMPONENT

Model Number DLXPLXXX

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, the patient was revised due to unknown reasons.

Manufacturer Narrative

Update product id information with a partial part number.Microport was unable to obtain further information for this incident.

• Brand Name: DYNASTY 15DEG CROSS-LINKED POLYETHYLENE LINER
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11586312
• MDR Text Key: 242883959
• Report Number: 3010536692-2021-00183
• Device Sequence Number: 1
• Product Code: MRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DLXPLXXX
• Device Catalogue Number: DLXPLXXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/11/2021
• Date Manufacturer Received: 03/11/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention