MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM; HIP COMPONENT

Model Number	38AM5435
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, removed original head and neck.Revision due to femoral head disassociating from the neck trunion.
Additional Manufacturer Narrative
The alleged complaint could not be confirmed.Review of the complaint, (b)(4) lot 017394109 and pha01222 lot 109u108524001, does not reveal any failure involving these implants.These implants have not been received for over 75 days; therefore, this complaint will be investigated without the devices available.No images or other medical documentation was provided to assist in the complaint investigation.Lot 017394109 was manufactured in 2007.Review of the design history record (dhr) for this subject manufacturing lot indicates that this implant was manufactured to specification.It is unknown when lot 109u108524001 was manufactured, or if it was manufactured to specification because mpo was unable to locate the dhr for this lot.There are no trends for these implants and failures.Without more information, it is not possible to confirm the alleged failure, or to determine the cause of the alleged failure.According to the mpo hip systems package insert (150803-9)? prior to assembly, surgical debris and fluid must be cleaned from the interior of the female seat to ensure proper locking.Ensure components are firmly seated to prevent disassociation.It 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: CONSERVE® A-CLASS® BFH® HEAD LONG NECK 54MM
• 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: 21597932
• Report Number: 3010536692-2025-00135
• Device Sequence Number: 21102298
• Product Code: LZO
• UDI-Device Identifier: M68438AM54351
• UDI-Public: M68438AM54351
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021349
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

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: 38AM5435
• Device Catalogue Number: 38AM5435
• Device Lot Number: 017394109
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Sex: Unknown