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

Model Number	DBFRGE54
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, acetabular shell appeared loose on x-ray.Additional information received on 11/13/2025: the cup was explanted and replaced with a depuy cup.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Mpo was notified that this patient was revised approximately 31 months after the index operation due to alleged loosening of the dynasty® biofoam® acetabular shell.The report notes that the shell appeared to have not been adequately fixed on x-ray.The explanted products were not returned to mpo for evaluation, nor were any images, radiographs, or operative notes provided to investigate the complaint.Review of the device history record (dhr) for these lots indicates that these products met all established acceptance criteria throughout manufacturing processes.Furthermore, this complaint is the first and only report involving the subject manufacturing lot.The quality of implant fixation is a known risk of total hip arthroplasty and can be influenced by component positioning, trauma, inadequate fixation, and/or tissue laxity, which is stated within the current microport hip systems package insert (150803-9).Without additional information, mpo is unable to provide conclusions regarding the alleged occurrence.There were no trends identified for this complaint.This complaint will continue to be monitored through complaint tracking.

• Brand Name: DYNASTY® BF SHELL REVISION 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: 23727954
• Report Number: 3010536692-2025-00389
• Device Sequence Number: 10375590
• Product Code: JDI
• UDI-Device Identifier: M684DBFRGE541
• UDI-Public: M684DBFRGE541
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K122382
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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: DBFRGE54
• Device Catalogue Number: DBFRGE54
• Device Lot Number: 1944521
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 01/28/2026
• 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
• Patient Sex: Male