MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® COCR LINER; HIP COMPONENT

Model Number DLCOGC36

Device Problem Material Disintegration (1177)

Patient Problems Pain (1994); Loss of Range of Motion (2032); Swelling (2091)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, patient underwent a revision surgery of her failed right total hip arthroplasty secondary to metal wear debris between modular components.Patient suffered persistent pain, swelling, elevated metal ions in the bloodstream, loss of mobility, and discomfort.

• Brand Name: DYNASTY® COCR LINER
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9647391
• MDR Text Key: 176987412
• Report Number: 3010536692-2020-00089
• Device Sequence Number: 1
• Product Code: JDL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DLCOGC36
• Device Catalogue Number: DLCOGC36
• Device Lot Number: 039808007
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/13/2020
• Date Manufacturer Received: 01/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention