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

Model Number KPONTP38

Device Problem Loss of Osseointegration (2408)

Patient Problem Insufficient Information (4580)

Event Date 08/29/2023

Event Type  Injury  

Manufacturer Narrative

This event will be updated once the investigation is complete.Trends will be evaluated.

Event 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
• Type of Device: 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
• MDR Text Key: 325249948
• Report Number: 3010536692-2023-00177
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: M684KPONTP381
• UDI-Public: M684KPONTP381
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K953439
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/12/2023
• Initial Date FDA Received: 10/09/2023
• Supplement Dates Manufacturer Received: 09/12/2023
• Supplement Dates FDA Received: 01/11/2024
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention