MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE II COCR TIBIAL BASE; KNEE COMPONENT

Model Number KTCCNPXX

Device Problem Insufficient Information (3190)

Patient Problem Bone Fracture(s) (1870)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, per paper by uyeama 2020 published in the journal the knee, patient was re-operated due to a peri-prosthetic fracture.Open reduction and internal fixation were performed and no components were remove.Components not revised: advance ii mp tibial insert product number: kimpxxxx, lot number: ni.Advance all-poly patella product number: ni, lot number: ni.

Manufacturer Narrative

No further information was received for this event.

• Brand Name: ADVANCE II COCR TIBIAL BASE
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 10976838
• MDR Text Key: 220469053
• Report Number: 3010536692-2020-00749
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Type of Report: Initial,Followup
• Report Date: 02/08/2021

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: KTCCNPXX
• Device Catalogue Number: KTCCNPXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/20/2020
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 02/08/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention