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

Model Number	DSBFGE54
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Naturally Worn (2988)
Health Effect - Clinical Code	Loss of Range of Motion (2032)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, revision due to liner disassociation.Surgeon suspects problem with cup.Product not revised: prglcle4 profemur® gladiator® classic plasma size 4 varus 8 dg neck, lot: 1787126, qty: 1.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• 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
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18325970
• Report Number: 3010536692-2023-00224
• Device Sequence Number: 15191470
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGE541
• UDI-Public: M684DSBFGE541
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K082924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

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: 1787915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Sex: Male