MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4+ 17MM RIGHT; KNEE COMPONENT

Model Number EIS4P17R

Device Problem Loss of Osseointegration (2408)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 12/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, an implant replacement was performed due too loosening.Replaced by eis4p20r evolution® mp cs insert size 4 plus 20mm right.(b)(4).

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 4+ 17MM RIGHT
• Type of Device: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer (Section G): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• Manufacturer Contact: 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 13108733
• MDR Text Key: 282898809
• Report Number: 3010536692-2021-00604
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS4P17R1
• UDI-Public: M684EIS4P17R1
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS4P17R
• Device Catalogue Number: EIS4P17R
• Device Lot Number: 1731109
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/02/2021
• Date Manufacturer Received: 12/02/2021
• 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