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

Model Number	DLXPGE36
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the first hip surgery failed for unknown reasons.(right hip) additional information received on 10/29/2020: both invoices original and revision surgery received, product id's were obtained.Additional information received on 10/30/2020: reason for device failure (poly liner slipped) and patient's age.Additional information received on 11/17/2020: updating implant date and adding patient's date of birth.Components not revised: dynasty® pc shell 54mm group e / catalog number: dspcge54 / lot number: 1699190.Cancellous self-tapping 6.5mm bone screw 3.0cm length / catalog number: 18080303 / lot number: 1717319.Profemur® preserve classic / catalog number: pprcle08 / lot number: 1699617.

• Brand Name: DYNASTY A-CLASS STD POLY LINER 36MM GROUP E
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10879615
• Report Number: 3010536692-2020-00703
• Device Sequence Number: 14266506
• Product Code: JDI
• UDI-Device Identifier: M684DLXPGE361
• UDI-Public: M684DLXPGE361
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K070785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2020

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: DLXPGE36
• Device Catalogue Number: DLXPGE36
• Device Lot Number: 1704568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2020
• Initial Report FDA Received Date: 11/20/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR