MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 52MM GROUP D; HIP COMPONENT

Model Number	DSBFGD52
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated when investigation is complete.
Event or Problem Description
Allegedly, patient had failed total hip right loose acetabular component patient underwent r hip revision replacement of acetabular shell cup cage, acetabular fracture and loose acetabular component.
Additional Manufacturer Narrative
Please void this report.This report is a duplicate of incident 16030036 that was mistakenly re-entered as a new incident.This incident will be re-reported as a follow-up under incident 16030036.
Event or Problem Description
Allegedly, patient had failed total hip right loose acetabular component patient underwent r hip revision replacement of acetabular shell cup cage, acetabular fracture and loose acetabular component.

• Brand Name: DYNASTY® BF SHELL 52MM GROUP D
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9182520
• Report Number: 3010536692-2019-01087
• Device Sequence Number: 14095361
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGD521
• UDI-Public: M684DSBFGD521
• Combination Product (Y/N): N
• PMA/510(K) Number: K082924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2020

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: DSBFGD52
• Device Catalogue Number: DSBFGD52
• Device Lot Number: 1101216630
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/13/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 09/13/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 01/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Weight: 29