MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. CERAMIC FEMORAL HEAD; HIP COMPONENT

Model Number 26000005

Device Problems Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event Description

Allegedly, patient was removing items from his storage unit and felt a large pop in his hip and fell to the ground.He was taken to the emergency room due to pain and was diagnosed with femoral neck fracture.On or about (b)(6) 2021 due to the failure of the device, patient?s device was surgically removed in a surgical procedure commonly called a revision.During his revision surgery the dr noted the neck had fractured at the insertion of the neck into the stem.Due to the failure of his profemur total hip system, the dr needed to remove the well-fixed femoral stem which required used of an extended trochanteric osteotomy.This procedure required an induced femoral stem fracture so as to loosen the component from the bone in order to allow extraction.

Manufacturer Narrative

Due to additional information received from the microport orthopedics reliability engineer and analysis, the product listed in the initial report as 26000005 ceramic femoral head, lot no.: 01971800601, has been analysis, the product listed in the initial report as 26000005 ceramic femoral head, lot no: 01971800601; has had the pain code replaced with the code 'not complaint stated' as there is no complaint/deficiency against this device.Please void this report.

• Brand Name: CERAMIC FEMORAL HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 13124742
• MDR Text Key: 283079274
• Report Number: 3010536692-2021-00616
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: M684260000051
• UDI-Public: M684260000051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 26000005
• Device Catalogue Number: 26000005
• Device Lot Number: 01971800601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/13/2021
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male