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

Model Number	26000005
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	Toxicity (2333)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: HIP COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10371206
• Report Number: 3010536692-2020-00559
• Device Sequence Number: 2686951
• Product Code: MRA
• UDI-Device Identifier: M684260000051
• UDI-Public: M684260000051
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P030027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/05/2020
• Supplement Report FDA Received Date: 12/07/2020
• Patient Sequence Number: 1
• Patient Weight: 90