MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 15DG POLY LINER 36MM GROUP F; HIP COMPONENT

Model Number	DLXPLF36
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient underwent left thr on (b)(6) 2017.Revised on (b)(6) 2022 due to dislocation.Initially surgeon replaced head, then cup, then stem until hip eventually became stable.All components removed and replaced with another manufacturer's system.(b)(6).

• Brand Name: DYNASTY® A-CLASS® 15DG POLY LINER 36MM GROUP F
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 15625152
• Report Number: 3010536692-2022-00362
• Device Sequence Number: 6345105
• Product Code: JDI
• UDI-Device Identifier: M684DLXPLF361
• UDI-Public: M684DLXPLF361
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K070785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: DLXPLF36
• Device Catalogue Number: DLXPLF36
• Device Lot Number: 1582830
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/06/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 10/18/2022
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male