MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. DYNASTY® A-CLASS® STD POLY LINER 36MM GROUP E; HIP COMPONENT

Model Number	DLXPGE36
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, liner wore through/became disassociated.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional Manufacturer Narrative
The alleged complaint is confirmed.Visual review of provided images and radiographic images of the implant, (b)(6) lot 1902296, reveals that the liner is worn and damaged and became disassociated.This implant was originally implanted in (b)(6) 2022 in the 60 yo male patient of medium activity level.This implant was revised in (b)(6) 2025 due to implant wear and dissociation.These failures were confirmed through four radiographic images provided.These images show the implant at 1-month post-surgery, 1-year post-surgery, 4 weeks prior to revision, and 1 week prior to revision.Explanted images of the liner show wear and deformation around the edges of the rim and lipped portions.It is unclear if this damage was caused by implant use or if the damage was caused by the surgeon attempts to remove the implant.Additionally, scratches and marks can be seen around and within the liner.This implant was manufactured in 2022.Review of the design history record (dhr) for the subject manufacturing lot indicates that this implant was manufactured to specification.There are no trends for this implant and failure with this being the first complaint for disassociation involving this family of implants received since october 2024.The current mpo hip systems package insert, (b)(6), includes the following statement as a postoperative precaution: "the patient must be advised of the limitations of the reconstruction and the need for protection of the prosthesis from full weight bearing until adequate fixation and healing have occurred.The patient should be cautioned to limit activities and protect the replaced joint from unreasonable stresses and possible loosening, fracture and/or wear, and follow the instructions of the physician with respect to follow-up care and treatment.Loosening of the components can result in increased production of wear particles, as well as damage to the bone, making successful revision surgery more difficult." this package insert also states, "periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.Periodic post-operative x-rays are recommended for close comparison with early post-op conditions to detect long term evidence of changes in position, loosening, bending, or cracking of components." mpo will continue to monitor this issue through complaint tracking.

• Brand Name: DYNASTY® A-CLASS® STD POLY LINER 36MM 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: 23767334
• Report Number: 3010536692-2025-00390
• Device Sequence Number: 10562692
• Product Code: JDI
• UDI-Device Identifier: M684DLXPGE361
• UDI-Public: M684DLXPGE361
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K070785
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 02/12/2026

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: DLXPGE36
• Device Catalogue Number: DLXPGE36
• Device Lot Number: 1902296
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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 Age: 63 YR
• Patient Sex: Male