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

Model Number 26000005

Device Problem Material Disintegration (1177)

Patient Problem Toxicity (2333)

Event Type  Injury  

Event Description

Allegedly, patient was revised due to cocr corrosion at the profemur® long neck, during the procedure dr.(b)(6) found severe metallosis involving the entire synovium.Components from another manufacturer: 48mm medacta versafit acetabular shell, 28mm medacta dual mobility poly liner.

Manufacturer Narrative

This event was already captured under report 3010536692-2020-00558.This report refers to an additional component associated to the event.During assessment of the investigation it was found that there was no alleged deficiency against this product.Therefore this component is not reportable.Please void the initial report.

• Brand Name: CERAMIC FEMORAL HEAD
• Type of Device: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10371206
• MDR Text Key: 201832125
• Report Number: 3010536692-2020-00559
• Device Sequence Number: 1
• Product Code: MRA
• UDI-Device Identifier: M684260000051
• UDI-Public: M684260000051
• Combination Product (y/n): N
• PMA/PMN Number: P030027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/07/2020

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
• Device Operator: Other
• Device Model Number: 26000005
• Device Catalogue Number: 26000005
• Device Lot Number: 1397433
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/14/2020
• Initial Date Manufacturer Received: 07/14/2020
• Initial Date FDA Received: 08/05/2020
• Supplement Dates Manufacturer Received: 07/14/2020
• Supplement Dates FDA Received: 12/07/2020
• Patient Sequence Number: 1
• Patient Weight: 90