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

Model Number DLCOGG44

Device Problem Material Disintegration (1177)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to corrosion at the metal-metal junction between the cobalt-chromium modular neck and the titanium stem and the metal debris and ion cast off from the cobalt and chromium conserve femoral head and cobalt and chromium dynasty liner.Modular neck was removed and conserve femoral head was replaced with a polyethylene dual femoral head.

Manufacturer Narrative

Correction of implant date.Evaluation codes and the investigation remain as reported initially.

• 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: 10361953
• MDR Text Key: 201578196
• Report Number: 3010536692-2020-00548
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DLCOGG44
• Device Catalogue Number: DLCOGG44
• Device Lot Number: 059869519
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/13/2020
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 10/16/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention