MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® MP? CS INSERT SIZE 6 STANDARD 10MM LEFT; KNEE COMPONENT

Model Number EIS6S10L

Device Problem Difficult to Insert (1316)

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

Event Date 12/08/2021

Event Type  Injury  

Event Description

Allegedly, patient underwent primary tkr on (b)(6) 2021.During surgery, poly liner would not lock in after multiple attempts, captures were clear looked good and still would not lock in.Liner disposed of, new liner opened and fit fine.Surgery delayed by 40 mins.(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 6 STANDARD 10MM 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: 13112633
• MDR Text Key: 285674903
• Report Number: 3010536692-2021-00609
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684EIS6S10L1
• UDI-Public: M684EIS6S10L1
• 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,Followup
• Report Date: 02/23/2022

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: EIS6S10L
• Device Catalogue Number: EIS6S10L
• Device Lot Number: 1869728
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/12/2021
• Initial Date Manufacturer Received: 12/12/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 12/12/2021
• Supplement Dates FDA Received: 02/23/2022
• 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: 74 YR
• Patient Sex: Male