MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION TIBIAL BASE NONPOROUS; KNEE COMPONENT

Model Number ETPKNXXX

Device Problem Fracture (1260)

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, a study by al juhani et al reported 2 unrevised cases of "periprosthetic fractures" in patients implanted with an evolution primary knee.First event was captured under manufacturer reference number (b)(4).

Manufacturer Narrative

10.Additional information received on 16-aug-2021.Adverse events reported in the article are not medical device related, as clarified by dr.(b)(6) in saudi arabia (author of the article and owner of the study) please void the report.11.Corrected data: event not reportable.

• Brand Name: EVOLUTION TIBIAL BASE NONPOROUS
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 12275092
• MDR Text Key: 265123524
• Report Number: 3010536692-2021-00418
• 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
• Type of Report: Initial,Followup
• Report Date: 08/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ETPKNXXX
• Device Catalogue Number: ETPKNXXX
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/19/2021
• Date Manufacturer Received: 07/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other