MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® ONLAY ALL-POLY PATELLA 32MM TRI-PEG; KNEE COMPONENT

Model Number	KPONTP32
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, patient underwent l tkr on (b)(6) 2018.Revised on (b)(6) 2024 due to infection.All components revised with the evolution revision system.Australia-c24-065.
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluated.

• Brand Name: ADVANCE® ONLAY ALL-POLY PATELLA 32MM TRI-PEG
• 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: 18841832
• Report Number: 3010536692-2024-00127
• Device Sequence Number: 17961972
• Product Code: JWH
• UDI-Device Identifier: M684KPONTP321
• UDI-Public: M684KPONTP321
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/03/2024

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: KPONTP32
• Device Catalogue Number: KPONTP32
• Device Lot Number: UNKNOWN
• 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: 02/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 05/03/2024
• 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: 58 YR
• Patient Sex: Female