MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS INC. ADVANCE RECESSED ALL-POLY PATELLA LOW DOME 25MM; KNEE COMPONENT

Model Number	KPRC25LO
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event will be updated once the investigation is complete.Trends will be evaluate.
Event or Problem Description
Allegedly, patient was revised due to the patella is not sitting flush with the bone , it was removed and replace with another company's patella.(b)(6).Products nor revised: advance® biofoam® tibia base w/ screwholes size 4+ product id: ktscfm41, lot id: 1507186.Advance® press fit keel primary 15mm x size 4+/5/5+ product id: kspp1556, lot id: 1643668.Cancellous bone screw 6.5mm x 20m x 2 product id: 7552002000, lot id's: 1664710 and 1702907.Advance® primary femoral size 4 right porous product id: kftcpc4r, lot id: 1666205.Advance® double high tibial insert sz 4 right 17mm product id: kidh417r, lot id: 0285418821639748.

• Brand Name: ADVANCE RECESSED ALL-POLY PATELLA LOW DOME 25MM
• Common Device Name: KNEE COMPONENT
• Manufacturer (Section D): MICROPORT ORTHOPEDICS INC.; 5677 airline rd.; arlington TN 38002
• MDR Report Key: 9835140
• Report Number: 3010536692-2020-00234
• Device Sequence Number: 740474
• Product Code: JWH
• UDI-Device Identifier: M684KPRC25LO1
• UDI-Public: M684KPRC25LO1
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K935080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: KPRC25LO
• Device Catalogue Number: KPRC25LO
• Device Lot Number: 1694840
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/24/2020
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 03/16/2020
• Supplement Report FDA Received Date: 09/30/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention