MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. TIBIAL INSERT COMPONENT; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Catalog Number	151700714
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for increased swelling of left knee.Event is not serious and is considered mild.Event is possibly related to both device and procedure.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: TIBIAL INSERT COMPONENT
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 17488309
• Report Number: MW5121007
• Device Sequence Number: 15265475
• Product Code: JWH
• UDI-Device Identifier: 10603295055068
• UDI-Public: 10603295055068
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Catalogue Number: 151700714
• Device Lot Number: HG9487
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown