MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 50MM GROUP C; HIP COMPONENT

Model Number	DSBFGC50
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Hip Fracture (2349)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly, periprosthetic fracture of the acetabular component patient was seen in clinic post sx between jul 2015-jan 2013.Improvements were slow.Patient was not fully weight beaning.Patient ended up having a failed acetabular on (b)(6) 2013, the patient underwent a revision with cage reconstruction.

• Brand Name: DYNASTY® BF SHELL 50MM GROUP C
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9199995
• Report Number: 3010536692-2019-01096
• Device Sequence Number: 3031748
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGC501
• UDI-Public: M684DSBFGC501
• Combination Product (Y/N): N
• PMA/510(K) Number: K082924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/16/2019

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: DSBFGC50
• Device Catalogue Number: DSBFGC50
• Device Lot Number: 1423642
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2019
• Initial Report FDA Received Date: 10/16/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Weight: 29