MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY BF SHELL 54MM GROUP E; HIP COMPONENT

Model Number	DSBFGE54
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Information (3190)
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 was revised for aseptic loosening and metallosis was discovered intraoperative.Right hip.

• Brand Name: DYNASTY BF SHELL 54MM GROUP E
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9554261
• Report Number: 3010536692-2020-00014
• Device Sequence Number: 19581609
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGE541
• UDI-Public: M684DSBFGE541
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K082924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: Other
• Device Model Number: DSBFGE54
• Device Catalogue Number: DSBFGE54
• Device Lot Number: 1716335
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/09/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 12/09/2019
• Initial Report FDA Received Date: 01/06/2020
• Supplement Report FDA Received Date: 08/28/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention