MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY PC SHELL 56MM GROUP F; HIP COMPONENT

Model Number	DSPCGF56
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the x-ray showed dislocation of the acetabular liner with superior migration of the femoral head into the acetabulum.The physician found large loose poly fragment floating within the hip capsule as well as severe metallosis.Total hip components were removed.

• Brand Name: DYNASTY PC SHELL 56MM GROUP F
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10442427
• Report Number: 3010536692-2020-00587
• Device Sequence Number: 4283287
• Product Code: LZO
• UDI-Device Identifier: M684DSPCGF561
• UDI-Public: M684DSPCGF561
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K061547
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/24/2020

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: DSPCGF56
• Device Catalogue Number: DSPCGF56
• Device Lot Number: 1532952
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention