MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 14MM RIGH; KNEE COMPONENT

Model Number EIS5S14R

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, patient underwent r tkr on (b)(6) 2022.Revised on (b)(6) 2023 due to malalignment with a custom insert.Australia (b)(4).

Manufacturer Narrative

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

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 5 STANDARD 14MM RIGH
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: rachael wise ; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 18336384
• MDR Text Key: 330611723
• Report Number: 3010536692-2023-00228
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS5S14R1
• UDI-Public: M684EIS5S14R1
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EIS5S14R
• Device Catalogue Number: EIS5S14R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female