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

Catalog Number	151310060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	11/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Clinical adverse event received for heart failure.Event is not serious and is considered moderate.Event is possibly related to both device and procedure.Date of implant: on (b)(6) 2021.Date of event: on (b)(6) 2021.(right knee).Treatment: diagnostic intervention complaint number: (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, METAL/POLYMER, MOBILE B
• Manufacturer (Section D): DEPUY ORTHOPAEDICS
• MDR Report Key: 17488478
• Report Number: MW5121177
• Device Sequence Number: 7872409
• Product Code: NJL
• UDI-Device Identifier: 10603295043485
• UDI-Public: 10603295043485
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2023

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: 151310060
• Device Lot Number: J32U71
• 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