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

Model Number	DLXPGG36
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
Date of Event	04/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient experienced dislocation, loss of mobility, swelling, adverse tissue reaction, and pain due to metal-on-metal components.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
Additional information in description / section h.6 medical device codes added.
Event or Problem Description
Allegedly, the patient experienced dislocation, loss of mobility, swelling, adverse tissue reaction, and pain due to metal on-metal components.Additional information received on 2023-02-09: (b)(6) 2021 left soft tissue mass that has developed after having his left hip replaced.It does not cause pain to the pt.2021-04-28 pt.Broke his hip spontaneously while walking, he felt pain - fell off the truck at work a week earlier - the plastic piece from his thr has broken and can hear it (creaking/ quaking) when he walks (discomfort to walk).X-rays show possible polyethylene wear, the hardware itself remains intact.No periprosthetic fracture is identified.2021-05-11 no significant osteolysis is identified.The position of the acetabular component raise the possibility of loosening.2021-07-12 left total hip arthroplasty, i and d, and head and liner, cancelled pt.Feeling unwell.2021-09-02 tha revision surgery.(b)(6) 2021 left hip periprosthetic infection, pain.Irrigation and debridement with head and liner exchange.

• Brand Name: DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP G
• 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: 16283116
• Report Number: 3010536692-2023-00017
• Device Sequence Number: 5019981
• Product Code: JDI
• UDI-Device Identifier: M684DLXPGG361
• UDI-Public: M684DLXPGG361
• 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
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2023

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: DLXPGG36
• Device Catalogue Number: DLXPGG36
• Device Lot Number: 1732406
• 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: 01/13/2023
• Supplement Date Received by Manufacturer: 01/13/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 05/11/2023
• 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: Male