MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 38MM STD GROUP E CROSSLINKED PO; HIP COMPONENT

Model Number	DLXPGE38
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2024
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, during revision of a patient with a tha replacement in 2011, a liner and neck fracture were identified.The neck was confirmed on preoperative ct and the liner was found to have been damaged intraoperatively.The liner was damaged because it protruded from the cup.As for the neck, it is necessary to investigate the possibility of internal damage.Japan (b)(4).
Event or Problem Description
Allegedly, during revision of a patient with a tha replacement in 2011, a liner and neck fracture were identified.The neck was confirmed on preoperative ct and the liner was found to have been damaged intraoperatively.The liner was damaged because it protruded from the cup.As for the neck, it is necessary to investigate the possibility of internal damage.Japan oc-00000557.

• Brand Name: DYNASTY® A-CLASS® 38MM STD GROUP E CROSSLINKED PO
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 20587971
• Report Number: 3010536692-2024-00473
• Device Sequence Number: 8943839
• Product Code: LZO
• UDI-Device Identifier: M684DLXPGE381
• UDI-Public: M684DLXPGE381
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2024

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: Health Professional
• Device Model Number: DLXPGE38
• Device Catalogue Number: DLXPGE38
• Device Lot Number: 0801202959
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown