MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION®MP TIB KEELED NONPOR SIZE 6 STANDARD LEF; KNEE COMPONENT

Model Number ETPKN6SL

Device Problems Packaging Problem (3007); Noise, Audible (3273)

Patient Problems Pain (1994); Insufficient Information (4580)

Event Type  Injury  

Event Description

Allegedly, patient got a knee replacement on (b)(6)2019, and has been experiencing pain on it ever since.Patient is stating he needs a replacement but does not have a date.The knee is popping and clicking and has been since the initial surgery.

Manufacturer Narrative

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

Manufacturer Narrative

Updated: the "health effect clinical code" was changed, the correct code is 1994 instead 4580.

• Brand Name: EVOLUTION®MP TIB KEELED NONPOR SIZE 6 STANDARD LEF
• 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: 16939638
• MDR Text Key: 315312288
• Report Number: 3010536692-2023-00093
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN6SL1
• UDI-Public: M684ETPKN6SL1
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ETPKN6SL
• Device Catalogue Number: ETPKN6SL
• Device Lot Number: 1814722
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/17/2023
• 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