MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. EVOLUTION® POROUS KEEL PRIMARY; KNEE COMPONENT

Model Number	ETPK1556
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Inflammation (1932); Pain (1994)
Date of Event	11/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.
Event or Problem Description
(b)(4) - patient # (b)(6).Allegedly, patient had primary surgery (b)(6) 2021 on left knee.This is a post op complaint on (b)(6) 2022.Pes anserinus bursitis/pain of left knee.No revision at this point, pain is ongoing/resolved.No further details available.

• Brand Name: EVOLUTION® POROUS KEEL PRIMARY
• 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: 19503491
• Report Number: 3010536692-2024-00336
• Device Sequence Number: 7025511
• Product Code: MBH
• UDI-Device Identifier: M684ETPK15561
• UDI-Public: M684ETPK15561
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 08/12/2024

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: ETPK1556
• Device Catalogue Number: ETPK1556
• Device Lot Number: 1876882
• 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: 05/14/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/12/2024
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 60 KG