MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 32MM 15DG GROUP C CROSSLINKED P; HIP COMPONENT

Model Number	DLXPLC32
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Insufficient Information (4580)
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, mpo dynasty liner revised with the dynasty liner sourced in preparation for the suspected infection.Rep doesn?t have any information on any other components that may have been revised during this case.(b)(4).
Additional Manufacturer Narrative
Section b.5: additional information in description/ section d.1: brand name has been updated/ section d.4: model# and lot# has been updated.
Event or Problem Description
Allegedly, mpo dynasty liner revised with the dynasty liner sourced in preparation for the suspected infection.Rep doesn't have any information on any other components that may have been revised during this case.Additional information received 10 april 2024: patient did not have an infection.Therefore, the liner was not used during the first revision operation (incident group: (b)(4).The patient underwent a second revision operation a couple days later due to dislocation.The dynasty liner was then used during the second revision operation.(b)(4).

• Brand Name: DYNASTY® A-CLASS® 32MM 15DG GROUP C CROSSLINKED P
• 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: 19239943
• Report Number: 3010536692-2024-00284
• Device Sequence Number: 20598468
• Product Code: JDI
• UDI-Device Identifier: M684DLXPLC321
• UDI-Public: M684DLXPLC321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: Other
• Device Model Number: DLXPLC32
• Device Catalogue Number: DLXPLC32
• Device Lot Number: 1541875
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown