MAUDE Adverse Event Report: EVOLUTION® CEMENTED STEM EXT14MM X 75MM; KNEE COMPONENT

Model Number	ESC14075
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
Type of Reportable Event	Serious Injury
Event or Problem Description
Allegedly, a document was extracted by the pms team involving doctor (b)(6) (2021) from us, 100 patients implanted, 1 revision (instability) and 18 other complications this incident is capturing one of the 18 complications, positive infection in right tka 11 months post-operative.Per the provided report, this case was considered by the authors to be non-device related.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: EVOLUTION® CEMENTED STEM EXT14MM X 75MM
• Common Device Name: KNEE COMPONENT
• Manufacturer Contact: rachael wise ; microport orthopedics inc.; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19260932
• Report Number: 3010536692-2024-00301
• Device Sequence Number: 19478394
• Product Code: JWH
• UDI-Device Identifier: M684ESC140751
• UDI-Public: M684ESC140751
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/20/2024

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: ESC14075
• Device Catalogue Number: ESC14075
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 08/22/2024
• 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 Sex: Unknown