MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CONSERVE® BFH® HEAD 54MM MEDIUM NECK; HIP COMPONENT

Model Number	38015400
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
See attached.
Event or Problem Description
Allegedly, original surgery done in 2004, exact date unknown.Recently the patient suffered hip pain and underwent a revision hip replacement.The modular neck, conserve big femoral head and conserve cup were revised, and replaced with a s&n acetabular shell and liner (the surgeons standard product).A new modular neck was inserted, along with an mpo ceramic head.

• Brand Name: CONSERVE® BFH® HEAD 54MM MEDIUM NECK
• 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: 19519023
• Report Number: 3010536692-2024-00341
• Device Sequence Number: 15538146
• Product Code: KXA
• UDI-Device Identifier: M684380154001
• UDI-Public: M684380154001
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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: 38015400
• Device Catalogue Number: 38015400
• Device Lot Number: 065233873
• 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: 05/16/2024
• Initial Report FDA Received Date: 06/12/2024
• 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: 79 YR
• Patient Sex: Female