MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT; KNEE COMPONENT

Model Number EIS4S12L

Device Problems Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

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

Event Date 08/26/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Allegedly, component exchanged due to ligament loosening.The component eis4s12l , lot 1842498 was revised.Replacement of inserts.(b)(4).

• Brand Name: EVOLUTION® MP? CS INSERT SIZE 4 STANDARD 12MM LEFT
• 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: 12482813
• MDR Text Key: 271745543
• Report Number: 3010536692-2021-00521
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS4S12L1
• UDI-Public: M684EIS4S12L1
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: EIS4S12L
• Device Catalogue Number: EIS4S12L
• Device Lot Number: 1842498
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/30/2021
• Date Manufacturer Received: 08/30/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1