MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL 42MM BCH® FEMORAL HEAD; HIP COMPONENT

Model Number	38CH4200
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
Allegedly, a patient with bmi over 40 and has advised legal that brought surgeon to follow up with hospital.
Event or Problem Description
Allegedly, a patient with bmi over 40 and has advised legal that brought surgeon to follow up with hospital.Additional information received on 09-19-2025: the patient was experiencing pain, possibly from metal reaction between cocr modular neck and femoral stem.It was reported that bone and tissue was removed during the revision with visible evidence of a reaction.The cocr neck was replaced with a titanium modular neck.
Additional Manufacturer Narrative
Due to additional information received, it has been indicated the complaint does not allege deficiency in the product.Please void this report.

• Brand Name: CONSERVE® TOTAL 42MM BCH® FEMORAL HEAD
• 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: 22984223
• Report Number: 3010536692-2025-00313
• Device Sequence Number: 9177464
• Product Code: LZO
• UDI-Device Identifier: M68438CH42001
• UDI-Public: M68438CH42001
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K072656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 09/26/2025

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: 38CH4200
• Device Catalogue Number: 38CH4200
• Device Lot Number: 1599301
• 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: 08/12/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/05/2025
• Supplement Report FDA Received Date: 09/26/2025
• 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 Sex: Male