MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 36MM STD GROUP D CROSSLINKED POL; HIP COMPONENT

Model Number DLXPGD36

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Naturally Worn (2988)

Patient Problem No Information (3190)

Event Date 08/20/2019

Event Type  Injury  

Event Description

Allegedly the surgeon reported that the insert was loose and rolled inside the shell.The cup, insert, head and neck were revised.Head was articulating directly on the shell.Pre-op x-ray and components included.

• Brand Name: DYNASTY® A-CLASS® 36MM STD GROUP D CROSSLINKED POL
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9126000
• MDR Text Key: 160251060
• Report Number: 3010536692-2019-01052
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: M684DLXPGD361
• UDI-Public: M684DLXPGD361
• Combination Product (y/n): N
• PMA/PMN Number: K061547
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DLXPGD36
• Device Catalogue Number: DLXPGD36
• Device Lot Number: 1579158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/28/2019
• Date Manufacturer Received: 08/28/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR