MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® TOTAL 38MM BCH® FEMORAL HEAD; HIP COMPONENT

Model Number	38CH3800
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/04/2023
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, on (b)(6) 2015, the patient had a total left hip replacement and received a wright profemur stem, the size 9, standard offset dynasty shell size 54, class a liner, size 38 and 6.5 x 35 mm.Cancellous screw, sleeve for the short neck and the ceramic 38 mm.Head.On (b)(6) 2023 ( less than 8 yrs.After the surgery) at 6:00 am lying in bed there was a loud pop and the patient could not use his left leg.He went to the local emergency room where they took an x-ray and stated "your hip device has failed".The x-ray revealed a fracture in the ceramic head of the hip device.By the time the patient could get a hip revision surgery on (b)(6), the ceramic head had broken in to 15-20 shards which the surgeon had to remove.The patient has now recovered and is physically better.The patient is writing because he believes he is entitled to some sort of compensation for the failure of the hip device and consequent physical and emotional distress.

• Brand Name: CONSERVE® TOTAL 38MM 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: 18760326
• Report Number: 3010536692-2024-00095
• Device Sequence Number: 20462330
• Product Code: LZO
• UDI-Device Identifier: M68438CH38001
• UDI-Public: M68438CH38001
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072656
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 04/08/2025

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: 38CH3800
• Device Catalogue Number: 38CH3800
• Device Lot Number: 1587829
• 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: 01/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 04/08/2025
• 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