MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY BF SHELL PRIMARY 58MM GROUP G; HIP COMPONENT

Model Number	DBFPGG58
Medical Device Problem Codes	Unstable (1667); Loss of Osseointegration (2408)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, patient revised for instability with a dual mobility cup.Component not revised: profemur renaissance stem long product id: plles013 lot no.: 1617782.

• Brand Name: DYNASTY BF SHELL PRIMARY 58MM GROUP G
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 11562178
• Report Number: 3010536692-2021-00167
• Device Sequence Number: 11957496
• Product Code: JDI
• UDI-Device Identifier: M684DBFPGG581
• UDI-Public: M684DBFPGG581
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K122382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/24/2021

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: DBFPGG58
• Device Catalogue Number: DBFPGG58
• Device Lot Number: 1700902
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/03/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR