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

Catalog Number	151316110
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 STEM
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): DEPUY ORTHOPAEDICS, INC.
• MDR Report Key: 17488325
• Report Number: MW5121023
• Device Sequence Number: 20644494
• Product Code: JWH
• UDI-Device Identifier: 10603295043676
• UDI-Public: 10603295043676
• 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: 151316110
• Device Lot Number: HK9240
• 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