MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® BF SHELL 56MM GROUP F; HIP COMPONENT

Model Number	DSBFGF56
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Metal Related Pathology (4530)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, the patient underwent l thr on (b)(6)2020.Revised on (b)(6)2020 due to metallosis.Femoral head revised with another mpo head, shell and liner revised with another manufacturer's acetabular components.Ref (b)(4).Non-mpo devices: 1.Acetabular insert ref: (b)(4).2.Acetabular shell ref: (b)(4).
Event or Problem Description
Allegedly, the patient underwent l thr on (b)(6) 2020.Revised on (b)(6) 2020 due to metallosis.Femoral head revised with another mpo head, shell and liner revised with another manufacturer's acetabular components.Ref (b)(4).Non-mpo devices: 1.Acetabular insert ref: (b)(4).2.Acetabular shell ref: (b)(4).

• Brand Name: DYNASTY® BF SHELL 56MM GROUP F
• 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: 21939892
• Report Number: 3010536692-2025-00214
• Device Sequence Number: 9055854
• Product Code: JDL
• UDI-Device Identifier: M684DSBFGF561
• UDI-Public: M684DSBFGF561
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K082924
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 08/13/2025

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: Health Professional
• Device Model Number: DSBFGF56
• Device Catalogue Number: DSBFGF56
• Device Lot Number: 1760188
• 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: 04/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male