MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 42MM STD GROUP G CROSSLINKED POL; HIP COMPONENT

Model Number	DLXPGG42
Medical Device Problem Code	Naturally Worn (2988)
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, patient claims that the liner that was inserted has slipped and it's not in the exact position anymore.Additional information received on 2023-07-19: patient gave his x-rays to the doctor on (b)(6) 2023 and he had thought the liner had slipped.The doctor told him he just had increase wear on the liner from it being off centered and he is being recommended to be replace with a bipolar.Other side is positioned correctly and he has no issues with it.

• Brand Name: DYNASTY® A-CLASS® 42MM STD GROUP G CROSSLINKED POL
• 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: 17500160
• Report Number: 3010536692-2023-00151
• Device Sequence Number: 17841734
• Product Code: JDI
• UDI-Device Identifier: M684DLXPGG421
• UDI-Public: M684DLXPGG421
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 10/16/2023

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: DLXPGG42
• Device Catalogue Number: DLXPGG42
• Device Lot Number: 1XXXXXX
• 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: 07/18/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 08/10/2023
• Supplement Report FDA Received Date: 10/16/2023
• 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