MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® 36MM 15DG GROUP D CROSSLINKED PO; HIP COMPONENT

Model Number	DLXPLD36
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Pain (1994)
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, the patient has pain and loosening.
Event or Problem Description
Allegedly, the patient has pain and loosening.Additional information received on april 6, 2022: allegedly, patient had pain and recurrent instability.The cup, screws, liner, head and neck were revised.The stem pha00606, stem revision "profemur® z", lot: 068501170 was not revised.Additional information received on may 3, 2022: during revision surgery, patient received implanted a phac1252 profemur® neck var/val 8dg short cobalt chrome and a 26000020 cocr transcend® femoral head 28mm slt taper x-long from wright medical.Patient received also a liner, insert and acetabular shell from stryker medical.Patient has been complaining of unknown issues since her revision on (b)(6) 2017.This complaint has been captured under microport reference group number: (b)(4).

• Brand Name: DYNASTY® A-CLASS® 36MM 15DG GROUP D CROSSLINKED PO
• 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: 13061079
• Report Number: 3010536692-2021-00596
• Device Sequence Number: 11164894
• Product Code: JDI
• UDI-Device Identifier: M684DLXPLD361
• UDI-Public: M684DLXPLD361
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2022

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: Other
• Device Model Number: DLXPLD36
• Device Catalogue Number: DLXPLD36
• Device Lot Number: 1561815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2021
• Supplement Date Received by Manufacturer: 12/01/2021
• Initial Report FDA Received Date: 12/22/2021
• Supplement Report FDA Received Date: 07/21/2022
• 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: Female