MAUDE Adverse Event Report: EVOLUTION® REV TIB HALF AUGSIZE 4 5MM LATERAL; KNEE COMPONENT

Model Number	ETH405L0
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Infection (1930)
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
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.

• Brand Name: EVOLUTION® REV TIB HALF AUGSIZE 4 5MM LATERAL
• Common Device Name: KNEE COMPONENT
• Manufacturer Contact: rachael wise ; microport orthopedics inc.; 5677 airline road; arlington, TN 38002 ; 9018674771
• MDR Report Key: 19261546
• Report Number: 3010536692-2024-00304
• Device Sequence Number: 16815656
• Product Code: JWH
• UDI-Device Identifier: M684ETH405L01
• UDI-Public: M684ETH405L01
• 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): 07/12/2024

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: ETH405L0
• Device Catalogue Number: ETH405L0
• Device Lot Number: 1790897
• 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: 07/12/2024
• 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 Sex: Unknown