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

Model Number	ETPKN6SL
Medical Device Problem Codes	Packaging Problem (3007); Noise, Audible (3273)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Additional 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
• Common Device Name: 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
• Report Number: 3010536692-2023-00093
• Device Sequence Number: 15297591
• Product Code: HRY
• UDI-Device Identifier: M684ETPKN6SL1
• UDI-Public: M684ETPKN6SL1
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K093552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2023

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2023
• Supplement Date Received by Manufacturer: 04/17/2023; 04/17/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 05/16/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown