MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE® ONLAY ALL-POLY PATELLA 38MM TRI-PEG; KNEE COMPONENT

Model Number	KPONTP38
Medical Device Problem Code	Loss of Osseointegration (2408)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/29/2023
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, patient underwent l tkr on (b)(6) 2015.Patella and tibial insert revised on (b)(6) 2023 and replaced with implants of the same size.The surgeon suspected the patella was never seated correctly when implanted.It was hanging off the side of the patella.Tibial insert replaced just in case while the knee was open.(b)(4).

• Brand Name: ADVANCE® ONLAY ALL-POLY PATELLA 38MM 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: 17894283
• Report Number: 3010536692-2023-00177
• Device Sequence Number: 16985877
• Product Code: JWH
• UDI-Device Identifier: M684KPONTP381
• UDI-Public: M684KPONTP381
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K953439
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 01/11/2024

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: KPONTP38
• Device Catalogue Number: KPONTP38
• Device Lot Number: 15754571579180
• 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: 09/12/2023
• Supplement Date Received by Manufacturer: 09/12/2023
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 01/11/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown