MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY A-CLASS STD POLY LINER 36MM GROUP F; HIP COMPONENT

Model Number	DLXPGF36
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, poly wear with heads now bearing against metal shell.No osteolysis seen on x-ray.No revision done yet.

• Brand Name: DYNASTY A-CLASS STD POLY LINER 36MM GROUP F
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11912693
• Report Number: 3010536692-2021-00312
• Device Sequence Number: 3197873
• Product Code: JDI
• UDI-Device Identifier: M684DLXPGF361
• UDI-Public: M684DLXPGF361
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K070785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2021

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
• Operator of Device: Other
• Device Model Number: DLXPGF36
• Device Catalogue Number: DLXPGF36
• Device Lot Number: 1647157
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/11/2021
• Initial Date Received by Manufacturer: 05/11/2021
• Supplement Date Received by Manufacturer: 05/11/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/01/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR
• Patient Weight: 88